(54 days)
Not Found
No
The document describes a spinal rod system and its intended use, focusing on mechanical components and surgical indications. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
Yes.
The device, a spinal rod system, is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for treating various acute and chronic instabilities or deformities. These functions directly address pathologies and aim to restore function, classifying it as a therapeutic device.
No
The device, a spinal rod system, is described as providing "immobilization and stabilization of spinal segments as an adjunct to fusion" for various spinal conditions. It is used in the treatment, not for diagnosis, of these conditions.
No
The device description explicitly states that the device is a "Spinal Rod" made of "Commercially Pure Titanium," which is a physical hardware component. The summary also mentions "biomechanical test data" related to the rod.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the device is a "Spine System" consisting of "spinal rods" and associated components like "screws, hooks, and connectors." These are implants designed for surgical use within the body.
- Intended Use: The intended use describes the device's purpose as providing "immobilization and stabilization of spinal segments" and being used for "noncervical pedicle fixation and nonpedicle fixation" in the treatment of various spinal conditions. This is a surgical intervention, not a diagnostic test performed on a sample outside the body.
Therefore, the device described is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The EXPEDIUM™ Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
The MOSS MIAMI™ Spine System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
The MOSS MIAMI™ Spine Systems is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
The MOSS MIAMI™ Spine System is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).
The EXPEDIUM™ Spine System 5.5mm Commercially Pure Titanium Rods may be used with mating titanium alloy components of the MOSS MIAMI™ Spine System which can accept a 5.5 mm diameter rod.
The MONARCH™ Spine System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neuroloqical impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
The MONARCH™ Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autoqenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
The MONARCH™ Spine System is also a hook and sacralliliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).
The MONARCH™ Spine System when used with pedicle screws are indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine.
The MONARCH™ Spine System Dual Rod Connectors can be used to connect MONARCH Spine System Rods to rods of other DePuy Spine 4.75mm, 5.5mm, and 6.35mm diameter rod systems.
The EXPEDIUM™ Spine System 5.5mm Commercially Pure Titanium Rods may be used with mating titanium alloy components of the MONARCH™ Spine System which can accept a 5.5 mm diameter rod
Product codes (comma separated list FDA assigned to the subject device)
NKB, MNI, MNH, KWP, KWQ
Device Description
The EXPEDIUM™ Spine System Commercially Pure Titanium Spinal Rods are 5.5mm diameter rods available in various lengths. The rods are designed for use with previously cleared titanium alloy components of the EXPEDIUM™ Spine System, MOSS MIAMI™ Spinal System, and MONARCH™ Spine System which can accept a 5.5mm spinal rod, including monoaxial and polyaxial screws, hooks, and connectors. The rods will be labeled as components of the EXPEDIUM™ Spine System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
noncervical pedicle, spinal, thoracic, lumbar, sacral, L5-S1 vertebra, L3 to sacrum
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)
Biomechanical test data were submitted to characterize the EXPEDIUM™ Spine System 5.5mm Commercially Pure Titanium Spinal Rod.
Biomechanical test data were submitted to characterize the 5.5mm Commercially Pure Titanium Spinal Rods.
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.
K033901, K955348, K024348, K021148
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
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
0
・K052i31 [EXPEDIUM Spine System] Page 1 of 1
510(k) Summary
| SUBMITTER: | DePuy Spine, Inc.
325 Paramount Drive
Raynham, MA 02780 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Liz Lavelle |
| DATE PREPARED: | August 4, 2005 |
| CLASSIFICATION NAME: | Appliance, Fixation, Spinal Interlaminal
Orthosis, Spinal Pedicle Fixation |
| PROPRIETARY NAME: | EXPEDIUM™ Spine System 5.5mm Commercially Pure
Titanium Spinal Rods |
| PREDICATE DEVICES: | EXPEDIUM™ Spine System (Merlin Spine System) -
K033901
MOSS MIAMI™ Spinal System - K955348
MONARCH™ Spine System - K024348, K021148 |
| DEVICE DESCRIPTION: | The EXPEDIUM™ Spine System Commercially Pure
Titanium Spinal Rods are 5.5mm diameter rods available
in various lengths. The rods are designed for use with
previously cleared titanium alloy components of the
EXPEDIUM™ Spine System, MOSS MIAMI™ Spinal
System, and MONARCH™ Spine System which can
accept a 5.5mm spinal rod, including monoaxial and
polyaxial screws, hooks, and connectors. The rods will be
labeled as components of the EXPEDIUM™ Spine
System. |
| INTENDED USE: | The EXPEDIUM™ Spine System is intended for noncervical
pedicle fixation and nonpedicle fixation for the following
indications: degenerative disc disease (defined as back pain
of discogenic origin with degeneration of the disc confirmed
by history and radiographic studies); spondylolisthesis;
trauma (i.e., fracture or dislocation); spinal stenosis;
curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor;
pseudoarthrosis; and failed previous fusion in skeletally
mature patients. |
| MATERIALS: | Manufactured from Grade 3 commercially pure titanium
conforming to ASTM F-67. |
| PERFORMANCE
DATA: | Biomechanical test data were submitted to characterize the
EXPEDIUM™ Spine System 5.5mm Commercially Pure
Titanium Spinal Rod. |
1
510(k) Summary
IX. 510(k) Summary
| SUBMITTER: | DePuy Spine, Inc.
325 Paramount Drive
Raynham, MA 02780 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Liz Lavelle |
| DATE PREPARED: | August 4, 2005 |
| CLASSIFICATION NAME: | Appliance, Fixation, Spinal Interlaminal
Orthosis, Spinal Pedicle Fixation |
| PROPRIETARY NAME: | 5.5mm Commercially Pure Titanium Spinal Rods |
| PREDICATE DEVICES: | EXPEDIUM™ Spine System (Merlin Spine System) -
K033901
MOSS MIAMI™ Spinal System - K955348
MONARCH™ Spine System - K024348, K021148 |
| DEVICE DESCRIPTION: | The Commercially Pure Titanium Rods are 5.5mm
diameter spinal rods available in various lengths. The rods
are designed for use with previously cleared titanium alloy
components of the MOSS MIAMI™ Spinal System which
can accept a 5.5mm spinal rod, including screws, hooks,
and connectors. |
| INTENDED USE: | The MOSS MIAMI™ Spine System is a pedicle screw
system intended to provide immobilization and stabilization
of spinal segments in skeletally mature patients as an
adjunct to fusion in the treatment of the following acute and
chronic instabilities or deformities of the thoracic, lumbar,
and sacral spine: degenerative spondylolisthesis with
objective evidence of neurological impairment, fracture,
dislocation, scoliosis, kyphosis, spinal tumor, and failed
previous fusion (pseudarthrosis).
The MOSS MIAMI™ Spine Systems is also indicated for
pedicle screw fixation for the treatment of severe
spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in
skeletally mature patients receiving fusion by autogenous
bone graft having implants attached to the lumbar and
sacral spine (L3 to sacrum) with removal of the implants
after the attainment of a solid fusion. |
2
· K052131 [Moss Miami Spine System] Page 2 of 2
The MOSS MIAMI™ Spine System is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).
The EXPEDIUM™ Spine System 5.5mm Commercially Pure Titanium Rods may be used with mating titanium alloy components of the MOSS MIAMI™ Spine System which can accept a 5.5 mm diameter rod.
MATERIALS: Manufactured from Grade 3 commercially pure titanium conforming to ASTM F-67.
PERFORMANCE DATA:
Biomechanical test data were submitted to characterize the 5.5mm Commercially Pure Titanium Spinal Rods.
3
510(k) Summary
'
| SUBMITTER: | DePuy Spine, Inc.
325 Paramount Drive
Raynham, MA 02780 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Liz Lavelle |
| DATE PREPARED: | August 4, 2005 |
| CLASSIFICATION NAME: | Appliance, Fixation, Spinal Interlaminal
Orthosis, Spinal Pedicle Fixation |
| PROPRIETARY NAME: | 5.5mm Commercially Pure Titanium Spinal Rods |
| PREDICATE DEVICES: | EXPEDIUM™ Spine System (Merlin Spine System) -
K033901
MOSS MIAMI™ Spinal System - K955348
MONARCH™ Spine System - K024348, K021148 |
| DEVICE DESCRIPTION: | The Commercially Pure Titanium Rods are 5.5mm
diameter spinal rods available in various lengths. The rods
are designed for use with previously cleared titanium alloy
components of the MONARCH™ Spinal System which
can accept a 5.5mm spinal rod, including screws, hooks,
and connectors. |
| INTENDED USE: | The MONARCH™ Spine System is a pedicle screw
system intended to provide immobilization and stabilization
of spinal segments in skeletally mature patients as an
adjunct to fusion in the treatment of the following acute and
chronic instabilities or deformities of the thoracic, lumbar,
and sacral spine: degenerative spondylolisthesis with
objective evidence of neurological impairment, fracture,
dislocation, scoliosis, kyphosis, spinal tumor, and failed
previous fusion (pseudarthrosis).
The MONARCH™ Spine System is also indicated for
pedicle screw fixation for the treatment of severe
spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in
skeletally mature patients receiving fusion by autogenous
bone graft having implants attached to the lumbar and
sacral spine (L3 to sacrum) with removal of the implants
after the attainment of a solid fusion. |
.
4
The MONARCH™ Spine System is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), turnor, and previous failed fusion (pseudarthrosis).
The MONARCH™ Spine System when used with pedicle screws are indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine.
The MONARCH™ Spine System Dual Rod Connectors can be used to connect MONARCH™ Spine System Rods to rods of other DePuy Spine 4.75mm, 5.5mm, and 6.35mm diameter rod systems.
The EXPEDIUM™ Spine System 5.5mm Commercially Pure Titanium Rods mav be used with mating titanium alloy components of the MONARCH™ Spine System which can accept a 5.5 mm diameter rod.
- MATERIALS: Manufactured from Grade 3 commercially pure titanium conforming to ASTM F-67.
PERFORMANCE DATA:
Biomechanical test data were submitted to characterize the 5.5mm Commercially Pure Titanium Spinal Rods.
5
Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is facing to the left. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 8 2005
Ms. Liz Lavelle Senior Regulatory Affairs Associate Depuy Spine 325 Paramount Drive Raynham, Massachusetts ()2767
Rc: K052131
Trade Name: Expedium™ Spine System, Moss Miami™ Spine System and Monarch™ Spine System (Addition of 5.5 CP Ti Rods) Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle Screw Spinal System Regulatory Class: III Product Code: NKB. MNI. MNH. KWP. KWQ Dated: September 2. 2005 Received: September 6, 2005
Dear Ms. Lavelle:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976. the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA`s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act s requirements, including, but not limited to: registration and fisting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
6
Page 2 -- Ms. Liz Lavelle
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Mark N. Milhim
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
7
Indications for Use lll.
510(k) Number (if known): K052131
Device Name: EXPEDIUM™ Spine System 5.5mm Commercially Pure Titanium Rods
Indications For Use:
The EXPEDIUM™ Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
510(k) Number_
Martin H. Wilkinson
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
8
III. Indications for Use
510(k) Number (if known): K052131
Device Name: 5.5mm Commercially Pure Titanium Rods to MONARCH™ Spine System
Indications For Use:
The MONARCH™ Spine System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neuroloqical impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
The MONARCH™ Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autoqenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
The MONARCH™ Spine System is also a hook and sacralliliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).
The MONARCH™ Spine System when used with pedicle screws are indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine.
The MONARCH™ Spine System Dual Rod Connectors can be used to connect MONARCH Spine System Rods to rods of other DePuy Spine 4.75mm, 5.5mm, and 6.35mm diameter rod systems.
The EXPEDIUM™ Spine System 5.5mm Commercially Pure Titanium Rods may be used with mating titanium alloy components of the MONARCH™ Spine System which can accept a 5.5 mm diameter rod
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
DePuy Spine, Inc. Special 510(k)
510(k) Number
9
lll. Indications for Use
510(k) Number (if known): K052131
Device Name: 5.5mm Commercially Pure Titanium Rods to MOSS MIAMI™ Spine System
Indications For Use:
The MOSS MIAMI™ Spine System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
The MOSS MIAMI™ Spine Systems is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion,
The MOSS MIAMI™ Spine System is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).
The EXPEDIUM™ Spine System 5.5mm Commercially Pure Titanium Rods may be used with mating titanium alloy components of the MOSS MIAMI™ Spine System which can accept a 5.5 mm diameter rod.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mar-
(Division Sign-Off) and Ne
DePuy Spine, Inc. Special 510(k)
510(k) Number