(79 days)
No
The document describes various spinal implants made of materials like carbon fiber reinforced polymer (CFRP) and PEEK. There is no mention of any software, algorithms, or data processing capabilities that would suggest the use of AI or ML. The device description focuses solely on the physical characteristics and intended use of the implants for spinal fusion and vertebral body replacement.
Yes.
The device is used to restore the height of a collapsed vertebral body, facilitate fusion in the spine, and treat fractures, which are all therapeutic interventions.
No
This device is an implantable intervertebral body fusion device and vertebral body replacement device, designed to restore biomechanical integrity and facilitate fusion in the spine. It is a therapeutic device, not a diagnostic one. While it mentions "radiographic studies" to confirm conditions, the device itself does not perform diagnostics.
No
The device description clearly states that the devices are physical implants made from materials like carbon fiber reinforced polymer (CFRP) and PEEK. These are hardware components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The descriptions clearly state that these devices are implants designed to be surgically placed within the body to provide structural support, facilitate fusion, or replace vertebral bodies in the spine. They are used in surgical procedures, not for testing biological samples.
- Lack of IVD Characteristics: The text does not mention any analysis of biological samples, reagents, or laboratory procedures, which are hallmarks of IVD devices.
Therefore, these devices fall under the category of implantable medical devices used in surgical procedures, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
CONCORDE, COUGAR, DEVEX, and LEOPARD Systems Indications.
The CONCORDE. COUGAR, DEVEX, and LEOPARD Systems are intervertebral body fusion devices in skeletally mature patients with degenerative discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the (L2-SI). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via either a PLIF (CONCORDE), TLIF (CONCORDE, DEVEX, LEÓPARD) or anterior (COUGAR) approach using autogenous bone. When used as interbody fusion devices are intended for use with DePuy Spine supplemental internal fixation.
The CONCORDE, COUGAR, DEVEX, and LEOPARD Systems are in the thoracolumbar spine (i.e., TI-LS) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anteriordecompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. These systems are also indicated for treating fractures of the thoracic and lumbar spine. These systems are designed to restore the biomechanial integrity of the anterior, middle and posterior spinal column even in the absence of fusion fora prolonged period. When used as a vertebral body replacement device these systems are intended for use with DePuy Spine supplemental internal fixation.
BENGAL System Indications The BENGAL System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one level of the with accompanying radicular symptoms. Patients should have six weeks of non-operative treatment prior to surgery. BENGAL implants are used to facilitate fusion in the cervical spine (C2-T) and are placed via an anterior approach using autogenous bone. When used as an interbody fusion device, DePuy Spine supplemental fixation should be used.
The BENGAL System is indicated for use in the thoracolumbar spine (i.e., T1-L5) to replace a diseased vertebral body resected or excised for the treatment of turnors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. This system is also indicated for treating fractures of the thoracic and lumbar spine. This system is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. When used as a vertebral body replacement device this system is intended for use with DePuy Spine supplemental internal fixation.
The VBR Spinal System is indicated for use in the thoracolumbar spine (i.e., T i to L5) to replace a diseased percei THE VON System is the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.
The VBR Spinal Systems are also indicated for treating fractures of the thoracic and lumbar spine.
The VBR Spinal Systems are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.
The VBR Spinal System is intended for use with supplemental internal fixation.
The Concorde VBR Spinal System is indicated for use in the thoracolumbar spine (i.e., T1-LS) to replace adiseased THE Occubrer TDA excised or excised for the treatment of tunors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.
The Concorde VBR Spinal System is also indicated for treating fractures of the thoracic and lumbar spine.
The Concorde VBR Spinal System is designed to restore the biomcchanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.
The Concorde VBR Spinal System is intended for use with supplemental internal fixation. The supplemental internal I xation systems that may be used with the Concorde VBR Spinal System include DePuy Spine titanium plate or rod systems (j.e., Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, T MX, MONARCH, Expedium, Viper, and Profile).
The DePuy AcroMed VBR System is indicated for use in the thoracolumbar spine (i.e., TI to I.S) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.
The DePuy AcroMed VBR System is also indicated for treating fractures of the thoracic and lumbar spinc.
The DoPuy AcroMed VBR System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.
The DePuy AcroMed VBR System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the VBR System include titanium plate or rod systems (i.e., Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, Monarch, and Profile).
The Devex Mcsh System is indicated for use in the thoracolumber spine (TI-I.S) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.
The Devex Mesh System is also indicated for treating fractures of the thoracic and lumbar spine.
The Devex Mesh System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.
The Devex Mesh System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the Surgical Titanium Mesh System include DePuy AcroMed titanium plate or rod systems (e.g. Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, Monarch and Profile).
The Stackable Cage System is indicated for use in the thoracolumbar spine (i.e., 'T to L5) to replace a diseased vertebral body resected or excised for the treatment of turnors, to achieve anterior decompression of the spinal cord neural tissues, and to restore the height of a collapsed vertebral body.
The Stackable Cage System is also indicated for treating fractures of the thoracic and lumbar spine.
The Stackable Cage System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.
The Stackable Cage System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the Stackable Cage System include DePuy AcroMed titanium plate or rod systems (e.g. Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, Profile).
Product codes (comma separated list FDA assigned to the subject device)
MQP, MAX, ODP
Device Description
BENGAL® System: The BENGAL® System is a carbon fiber reinforced polymer (CFRP) interbody fusion and VBR device. The cage distracts and maintains the intervertebral height, as well as providing restoration of cervical lordosis. The range of cages available is based on natural anatomical variation.
BENGAL® Stackable System: The Bengal® Stackable System is a radiolucent, multilevel corpectomy solution that provides a system approach to restoring natural lordosis. The BENGAL® Stackable Cage System offers versatility in footprint options (3 are available), height options (18 to 66 mm increments), and lordotic angle options. The stackable cages (LRG and XLG) are held together by a titanium locking screw and nut. The titanium locking screw is used for all stackable constructs.
CONCORDE® Bullet Lumbar Interbody System: The CONCORDE Bullet implants. manufactured from Carbon Fiber Reinforced Polymer (CFRP), are interbody cages designed with a bulleted nose for ease of insertion into the interbody space. The CONCORDE Bullet offers optimized area for bone graft and tantalum markers.
CONCORDE® Inline Lumbar Interbody System: The CONCORDE® Inline Lumbar Interbody System completes the offering within the CONCORDE® family of products with an implant designed to facilitate ease of posterior insertion and improve resistance to migration. The CONCORDE Inline is designed with a bulleted nose for ease of insertion into the interbody space and are manufactured from Carbon Fiber Reinforced Polymer (CFRP).
The COUGAR® System is an Anterior Spinal Implant System COUGAR® System: manufactured of Carbon Fiber Reinforced Polymer (CFRP). COUGAR® is available in three COUGAR® footprints - Small, Medium and Large and varying heights from 10-20mm. incorporates an anatomic design with 5, 10, 15, and 20 degrees of lordosis. The cages offer tantalum marker beads for radiographic location and orientation of the implant.
COUGAR® LS Lateral Cage System: The COUGAR® LS Lateral Cage System The COUGAR® LS Lateral Cage System consists of the PEEK/carbon fiber composite cages (CFRP).Cages are available in parallel or lordotic configurations and are available in various sizes to match patient anatomy. The cage structure is radiolucent with tantalum x-ray wire so that healing can be assessed by normal radiographic methods. The cages have teeth that resist rotation and migration and have cavities to accept packing of autogenous bone graft. The implants may be utilized in either an open or minimally invasive surgical approach. The implants areplaced using a lateral surgical approach.
DEVEX® System: The DEVEX® System is indicated for use in the thoracolumbar spine (i.e., T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The DEVEX® System is also indicated for treating fractures of the thoracic and lumbar spine. The DEVEX® System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.
LEOPARD® System: The LEOPARD® System is made of carbon fiber reinforced polymer (CFRP) material that has a modulus of elasticity approximating that of cortical bone. The LEOPARD® System meets the structural requirements of anterior column support while optimizing the fusion environment through an open, load-sharing design.
OCELOT® Stackable Cage System: The OCELOT® Stackable Cage System provides anterior column support for single or multi-level corpectomies or total vertebrectomies from T1 to 15. The system consists of one or more PEEK™ Carbon Fiber Polymer cages that are stacked to a desired height, accommodating various patient needs. The PEEK™ Carbon Fiber Reinforced Polymer material emulates the biomechanical properties of human cortical bone, optimizing the likelihood of a sound arthrodesis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lumbar spine (L2-S1), thoracolumbar spine (T1-L5), cervical spine (C2-T1)
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data is not provided in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K073649, K081917, K052746, K110694, K030833, K082128, K122896, K110454, K023835, K001340
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
A. Submitter Information
| Manufacturer: | Medos International Sárl
Chemin-Blanc 38
2400 Le Locle, Switzerland |
|-------------------|---------------------------------------------------------------------------|
| Submitter: | DePuy Synthes Spine
325 Paramount Drive
Raynham, MA 02767 |
| Contact Person: | Linda Bernier
325 Paramount Drive
Raynham, MA 02767 |
| Telephone number: | 508-828-2837 |
| Fax number: | 508-828-3797 |
| Email: | lbernier@its.jnj.com |
| Date Prepared | June 12, 2014 |
C. Device Name
B.
| Device Name > > Over-The-Counter Use (21 CFR 801 Subpart C)
14
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Anton E. Dmitriev, PhD Division of Orthopedic Devices
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human SeNices Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
CONCORDE® Inline Lumbar Interbody System
Indications for Use (Describe)
Indications for Use (Describe)
The CONCORDE, CONCORDE Bullet, CONCORDE Curve, COUGAR, DEVIX, and LEOPARD Systems are indicated The CONCORDE, CONCORDE Buile, CONCORDS Carrol vith degenerative disconcelive discopedia studies) on one of for use as interverted body itsion devices in skelcany matter part radiographic studies) at one of two discogenti back pan with degeneration of the dise committed of non-operative treatment prior to complois levels of the lumbal spine (22-31). I and more spine and are placed via either a PLIF (CONCORDE, surgery. These implans are used to acmare tusion in the balled, convel, DEVEX, LEONARD) or anterior CONCORDE Builet), TLIF (CONCORDE, CONCORDIT Builter, CONOCALD Gevices these implants are intended for use with DePuy Spine supplemental internal fixation products.
The CONCORDE, CONCORDE Builet, CONCORDE Curve, COUGAR,DEVEX, and LEDPARD Systems are indicated The CONCORDE, CONCORDE Buile, CONCORDE Care, CONOMICAL PLAY CHECHE OF CHE THE THE THE THE THE THE THE THE THE THE THE THE THE THE THE THE THE CELLED FOR for use in the thoracolumbas spine (t.e., 1 +1-3) is replace and to resore the height of a collepsed
of tumors, to achieve anterior decompression of the spiral conduction ins of tumors, to achieve anterior decompression of the not not nover of the shown is and umbar spine. These systems are
vertebral body. These systems are also indicated for midd vertebral body. These systems are also indicated to: middle and posted on spinal on umn even in the absence of designed to restore the biomethal integrity of the antenor, interest of these systems are intended for use with DePuy Spine supplemental internal fixation products.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
[] Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Anton E. Dmitriev, PhD
Division of Orthopedic Devices
16
Indications for Use
510(k) Number (if known)
Device Name
COUGAR® LS Lateral Cage System
Indications for Use (Describe)
indcations on Use (Dostallo)
The COUGAR LS Lateral Cage System is indicated for use in the thoracolumbar spine((.c., T'I to LS) to replace a I he COOOH LES Datan Cago Dytern is merce the the treatment of tumors, to achieve anterior decompression of the spinal cord and neural issues, and to restore the height of a collapsed vertebral body. This system is also indicated for treating fractures of the thoracic and lumbar spine. The system is designed to restore the biomechanical integrity of the anterior, middle and posterior spinst of the of seence of fusion for a prolonged period. When used as a vertebral body replacement device, this system is intended for use with DePuy Spine supplemental internal fixation.
The COUGAR LS Lateral Cage System is also indicated for intervertebral body fusion with and one grating to I he COUOAK LS Lateral Cage System is also muleated for meliguous levels from L2 to S1. These DDD patients may patients will degeneralive uiscase (DDD) at one onliness at the involved levels. DDD is defined as discogenic bask painter also have to the disc confirmed by history and radiographic studies. These patients should be skeletally mature with degentration of non-operative treatment. These implants may be implanted via an open or minimally a and have had six monits of low-operative firsting the resem is intended for use with DePuy Spine supplemental internal fixation.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
Please do not write below this line - continue on a separate page if needed.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Anton E. Dmitriev, PhD
Division of Orthopedic Devices
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the semplate I he burden time for this collection of inistmation is econder and maintals the data needed and completer time to review the collections, Send comments regarding this burden estimate or any other aspect
and review the collection of information. Send comments regarding to tax and taview the collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
*An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
17
Indications for Use
510(k) Number (if known) K140759
Device Name COUGAR® LS Lateral Cage System
Indications for Use (Describe)
indications for over is indicated for intervertebral body fusion with autogenous bone graft in patients with I he Lateral Cage Bysion is Interested in the release in the St. "These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with Orade 1 Spondytonshists of Ledonsmens at and involved with studies. These patients should be skeletally mature and degeneration of non-operative treatment. These implanted via an open or a minimally invasive have had six monula of not Ocage System is intended for use with DePuy Spine supplemental fixation.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
] Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Anton E. Dmitriev, PhD
Division of Orthopedic Devices
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the The burden time in this collection of information is osimilation is and mainting and completer aspect time to review the collection. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
EF PSC Publishing Services (701) 44) 474
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
18
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name BENGAL® Stackable System
Indications for Use (Describe)
The VBR Spinal System is indicated for use in the thoracolumbar spine (i.e., T i to L5) to replace a diseased percei THE VON System is the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.
The VBR Spinal Systems are also indicated for treating fractures of the thoracic and lumbar spine.
The VBR Spinal Systems are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.
The VBR Spinal System is intended for use with supplemental internal fixation.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
Please do not write below this line – continue on a separate page if needed.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Anton E. Dmitriev, PhD
Division of Orthopedic Devices
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the I he builden time for this collection of internation to oceasing the data needed and completer as any other spoct time to review institucions, Search existing detactived this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
: .
FORM FDA 3881 (1/14)
PSC Publishing Services (101) #43-6740 EP
19
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Orug Administration
Indications for Use
510(k) Number (if known)
K140759
Device Name CONCORDE® Bullet Lumbar Interbody System
Indications for Use (Describe)
The Concorde VBR Spinal System is indicated for use in the thoracolumbar spine (i.e., T1-LS) to replace adiseased THE Occubrer TDA excised or excised for the treatment of tunors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.
The Concorde VBR Spinal System is also indicated for treating fractures of the thoracic and lumbar spine.
The Concorde VBR Spinal System is designed to restore the biomcchanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.
The Concorde VBR Spinal System is intended for use with supplemental internal fixation. The supplemental internal I xation systems that may be used with the Concorde VBR Spinal System include DePuy Spine titanium plate or rod systems (j.e., Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, T MX, MONARCH, Expedium, Viper, and Profile).
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Anton E. Dmitriev, PhD
Division of Orthopedic Devices
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (1/14)
PSC Publishing Services (301) 441-6720
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
t
20
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name COUGAR® System
Indications for Use (Describe)
The DePuy AcroMed VBR System is indicated for use in the thoracolumbar spine (i.e., TI to I.S) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.
The DePuy AcroMed VBR System is also indicated for treating fractures of the thoracic and lumbar spinc.
The DoPuy AcroMed VBR System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.
The DePuy AcroMed VBR System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the VBR System include titanium plate or rod systems (i.e., Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, Monarch, and Profile).
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Anton E. Dmitriev, PhD
Division of Orthopedic Devices
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Sand comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
PSC Publishing Services (101) 443-6740 187
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
21
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration .
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K140759
Device Name DEVEX® System
Indications for Use (Doscribe)
The Devex Mcsh System is indicated for use in the thoracolumber spine (TI-I.S) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.
The Devex Mesh System is also indicated for treating fractures of the thoracic and lumbar spine.
The Devex Mesh System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.
The Devex Mesh System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the Surgical Titanium Mesh System include DePuy AcroMed titanium plate or rod systems (e.g. Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, Monarch and Profile).
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Anton E. Dmitriev, PhD
Division of Orthopedic Devices
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (1/14)
HE PSL Publicions Rervices (101) 41) 4740
22
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K140759
Device Name
OCELOT® Stackable Cage System
Indications for Use (Describe)
The Stackable Cage System is indicated for use in the thoracolumbar spine (i.e., 'T to L5) to replace a diseased vertebral body resected or excised for the treatment of turnors, to achieve anterior decompression of the spinal cord neural tissues, and to restore the height of a collapsed vertebral body.
The Stackable Cage System is also indicated for treating fractures of the thoracic and lumbar spine.
The Stackable Cage System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.
The Stackable Cage System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the Stackable Cage System include DePuy AcroMed titanium plate or rod systems (e.g. Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, Profile).
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
l_ | Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)
Anton E. Dmitriev, PhD
Division of Orthopedic Devices
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response. Including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Sand comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (1/14)
'5C Publishing Services (301) 44)-6749
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.