(97 days)
N/A
No
The summary describes a mechanical spinal implant system and its components. There is no mention of software, algorithms, or any features that would suggest the use of AI or ML.
Yes
The device is described as an "adjunct to fusion" and is intended for the treatment of various spinal instabilities and deformities, indicating its use in managing and treating medical conditions.
No
The provided text describes the "Innovasis Excella III-D Spinal Deformity System" as a system of implants (screws, hooks, rods, connectors) used to provide immobilization and stabilization of spinal segments as an adjunct to fusion. Its intended use is for the treatment of various spinal conditions, not for diagnosing them.
No
The device description explicitly details physical implants made of titanium alloy and Cobalt-28 Chromium-6 Molybdenum, including screws, hooks, rods, and connectors. There is no mention of software as the primary component or function of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system designed to provide immobilization and stabilization of spinal segments. This is a therapeutic and structural function within the body, not a diagnostic test performed on samples outside the body.
- Device Description: The device is described as a system of implants (screws, hooks, rods, connectors) made of titanium alloy and cobalt-chromium-molybdenum. These are physical components intended for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
The device is a spinal implant system used in surgical procedures, which falls under the category of medical devices, but not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Innovasis Excella III-D Spinal Deformity System, when used as a posterior pedicle screw system, is 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 disc disease (DDD-defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.
The Innovasis® Excella III-D® Spinal Deformity System, is also indicated for treatment of severe spondylolisthesis (Grades 3 & 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/illium.
When used as a posterior non-pedicle screw fixation system, the Innovasis® Excella III-D® Spinal Deformity System is intended for the treatment of degenerative disc disease (DDD-defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's disease), fracture, pseudoarthrosis, tumor resection, and/or failed previous fusion. Overall levels of fixation are T1-sacrum/illium.
When used as an anterolateral thoracolumbar system, the Innovasis Excella III-D Spinal Deformity System is intended for anterolateral screw fixation for the following indications: Degenerative disc disease (DDD-defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), fracture or dislocation of the thoracolumbar spine, pseudoarthrosis, tumor resection, and/or failed previous fusion. Levels of screw fixation are T8-L5.
Product codes
NKB, MNI, MNH, KWP, KWQ
Device Description
The Excella (//-D) pedicle screws, hooks and connectors are an adjunct to the Excella II® Spinal System. Both the Excella II Spinal System and Excella III-D Spinal Deformity System consist of 6Al-4V titanium alloy implants meant to be used in a system. The single use devices are offered in a variety of different configurations, including screw lengths ranging from 25mm to 100mm in the following diameters, 4.0mm (new size), 4.75mm, 5.5mm, 6.5mm, 7.5mm and 8.5mm; and various hooks, rods, and connectors-and are sold non-sterile. The Excella II screw implants are cannulated or solid while the Excella III-D implants are solid only. All pedicle screws and iliac screws feature identical multi-axial ioints for free motion of the screw head to allow the physician greater flexibility when placing the screws. The bone thread portion of the screws feature a self-tapping, double lead with an aggressive thread.
The Excella II and Excella III-D systems utilize identical 5.5mm titanium rods in various lengths from 35mm to 500mm (straight) or 35mm to 125mm (bent). The rods are placed in the head of the screws and the system is locked in place with titanium locking caps. The locking cap design includes a threaded locking screw attached to an alignment cap ("tulip"). Each locking cap includes a buttress thread design for axial strength and to prevent screw loosening. Excella III-D also features 5.5mm rods made from medical grade Cobalt-28 Chromium-6 Molybdenum, available in 500mm and 600mm lengths.
The Excella ///-D titanium screws also have available alignment caps with extended length head (reduction head) that can be broken off after installation. Once the locking screw has been tightened in place. the added length on the alignment cap can be broken off at a tab. resulting in a final profile and assembly that is identical to a standard Excella II screw and locking cap assembly.
The Excella III-D Spinal Deformity System includes multiple sizes of hooks for use primarily in the thoracic region, and rod connectors for extension of existing constructs. The additional rod connectors (five versions) have been added to the Excella III-D system to allow end-to-end connection of rods. These connectors will fit both 5.5mm and 6.0mm rods. The identical locking cap is used on all Excella // and Excella III-D pedicle screws, hooks and lateral connectors. The Excella III-D Spinal Deformity System includes additional instrumentation to aid in de-rotation of the spine in deformity cases.
The Excella cross connectors come in 20, 25, 30 or 35mm fixed and various adjustable lengths from 39 to 81mm to allow for variation in perpendicular placement on two rods. Each cross connector features a clamping mechanism to grip the rods and stabilize the relation between the rods, and will work with 5.5mm and 6.0mm rods. The 20 and 25mm (shorter) sizes are new to the system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar region, thoracic, lumbar, sacral spine, L5-S1 vertebra, lumbosacral spine, ilium, T1-sacrum/illium, T8-L5
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Users of these products are limited to physicians trained in orthopedic surgery. Clinical locations include hospitals and surgery sites equipped to perform spinal surgery.
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: (Non-clinical)-Performance testing per ASTM F1717 for Static Compression Bend, Static Torsion and Dynamic Compression Bend, Static and Dynamic Axial Compression Bend, and Axial Pullout Strength indicates that the Excella III-D Spinal Deformity System is capable of performing in accordance with its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K102248, K071921, K042143, K100788
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when 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: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
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K140238 - Page 1 of 4
510(k) Summary Report:
Excella III-D® Spinal Deformity System
January 28, 2014 Innovasis, Inc. Company: 614 E. 3900 South Salt Lake City, UT 84107
- Marshall C. McCarty Contact: Phone: (801) 261-2236 mmccarty@innovasis.com
- Excella® Spinal System Trade Name: Excella III-D®
- Common Name: Pedicle Screw Spinal System Non-pedicle Screw Fixation System
- Classification: Regulation No.: 21CFR 888.3070 Class 3 (Preamendment) Product Code: NKB, MNI, MNH Review Panel: Orthopedic Posterior Spine Devices Branch (PSDB)
Regulation No .: 21CFR 888.3050 Class 2 Product Code: KWP Review Panel: Orthopedic Posterior Spine Devices Branch (PSDB)
Regulation No .: 21CFR 888.3060 Class 2 Product Code: KWQ Review Panel: Orthopedic Posterior Spine Devices Branch (PSDB)
Applicable
Standards:
- · ASTM F543-07e1 Standard Specification and Test Methods for Metallic Medical Bone Screws. · ASTM F983-86 Standard Practice for Permanent Marking of Orthopedic Implant Components · ASTM F1717-13 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
1
| • ASTM F1798-97 | Standard Guide for Evaluating the Static and
Fatigue Properties of Interconnection
Mechanisms and Subassemblies Used in
Spinal Arthrodesis Implants |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| • ASTM F2193-02 | Standard Specifications and Test Methods for
Components Used in the Surgical Fixation of
the Spinal Skeletal System |
| • ISO 17665-1: 2006 | Sterilization of Healthcare Products - Moist
Heat - Part 1 Requirements for the
Development, Validation and Routine Control of
a Sterilization Process for Medical Devices |
Substantially
| Equivalent Device: | K102248 Excella II® Spinal System |
|---|---|
| K071921 Excella® Spinal System | |
| K042143 Excella®-M Spinal System | |
| K100788 Globus Revere® Stabilization System |
Device Description: The Excella (//-D) pedicle screws, hooks and connectors are an adjunct to the Excella II® Spinal System. Both the Excella II Spinal System and Excella III-D Spinal Deformity System consist of 6Al-4V titanium alloy implants meant to be used in a system. The single use devices are offered in a variety of different configurations, including screw lengths ranging from 25mm to 100mm in the following diameters, 4.0mm (new size), 4.75mm, 5.5mm, 6.5mm, 7.5mm and 8.5mm; and various hooks, rods, and connectors-and are sold nonsterile. The Excella II screw implants are cannulated or solid while the Excella III-D implants are solid only. All pedicle screws and iliac screws feature identical multi-axial ioints for free motion of the screw head to allow the physician greater flexibility when placing the screws. The bone thread portion of the screws feature a self-tapping, double lead with an aggressive thread.
The Excella II and Excella III-D systems utilize identical 5.5mm titanium rods in various lengths from 35mm to 500mm (straight) or 35mm to 125mm (bent). The rods are placed in the head of the screws and the system is locked in place with titanium locking caps. The locking cap design includes a threaded locking screw attached to an alignment cap ("tulip"). Each locking cap includes a buttress thread design for axial strength and to prevent screw loosening. Excella III-D also features 5.5mm rods made from medical grade Cobalt-28 Chromium-6 Molybdenum, available in 500mm and 600mm lengths.
The Excella ///-D titanium screws also have available alignment caps with extended length head (reduction head) that can be broken off after installation. Once the locking screw has been tightened in place. the added length on the alignment cap can be broken off at a tab. resulting in a final profile and assembly that is identical to a standard Excella II screw and locking cap assembly.
2
K140238 - Page 3 of 4
The Excella III-D Spinal Deformity System includes multiple sizes of hooks for use primarily in the thoracic region, and rod connectors for extension of existing constructs. The additional rod connectors (five versions) have been added to the Excella III-D system to allow end-toend connection of rods. These connectors will fit both 5.5mm and 6.0mm rods. The identical locking cap is used on all Excella // and Excella III-D pedicle screws, hooks and lateral connectors. The Excella III-D Spinal Deformity System includes additional instrumentation to aid in de-rotation of the spine in deformity cases.
The Excella cross connectors come in 20, 25, 30 or 35mm fixed and various adjustable lengths from 39 to 81mm to allow for variation in perpendicular placement on two rods. Each cross connector features a clamping mechanism to grip the rods and stabilize the relation between the rods, and will work with 5.5mm and 6.0mm rods. The 20 and 25mm (shorter) sizes are new to the system.
Performance Data: (Non-clinical)-Performance testing per ASTM F1717 for Static Compression Bend, Static Torsion and Dynamic Compression Bend, Static and Dynamic Axial Compression Bend, and Axial Pullout Strength indicates that the Excella III-D Spinal Deformity System is capable of performing in accordance with its intended use.
Materials : The implants are machined from medical grade titanium (6AL-4V ELI) per ASTM F136-12a. Additional rods are also available from medical grade Cobait-28 Chromium-6 Molybdenum per ASTM F1537-11.
Intended Use: Users of these products are limited to physicians trained in orthopedic surgery. Clinical locations include hospitals and surgery sites equipped to perform spinal surgery.
The Excella III-D® Spinal Deformity System is designed for spinal fixation procedures performed through a posterior or anterolateral approach, and is intended to assist in the temporary stabilization of spinal segments in order to provide an optimal environment for spinal fusion in the thoracolumbar region.
Indications for Use: The Innovasis Excella III-D Spinal Deformity System, when used as a posterior pedicle screw system, is 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 disc disease (DDD-defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.
The Innovasis® Excella III-D® Spinal Deformity System, is also indicated for treatment of severe spondylolisthesis (Grades 3 & 4) of
3
the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3sacrum/ilium.
When used as a posterior non-pedicle screw fixation system, the Innovasis® Excella III-D® Spinal Deformity System is intended for the treatment of degenerative disc disease (DDD-defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's disease), fracture, pseudoarthrosis, tumor resection, and/or failed previous fusion. Overall levels of fixation are T1-sacrum/illium.
When used as an anterolateral thoracolumbar system, the Innovasis Excella III-D Spinal Deformity System is intended for anterolateral screw fixation for the following indications: Degenerative disc disease (DDD-defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), fracture or dislocation of the thoracolumbar spine, pseudoarthrosis, tumor resection, and/or failed previous fusion. Levels of screw fixation are T8-L5.
Basis for Substantial Equivalence:
The Excella III-D Spinal Deformity System has been subjected to risk analysis, engineering analysis and testing to recognized standards and has been shown to be substantially equivalent to the predicate device, K102248, Excella II Spinal System.
- . Design configurations are substantially equivalent.
- . Applied mechanical loads are substantially equivalent.
- Materials used are equivalent (6Al 4V ELI titanium) or . substantially equivalent (Cobalt-28 Chromium-6 Molybdenum) and have been utilized in long term implants.
- Biocompatibility requirements have been demonstrated. .
- . Manufacturing and processing methods are equivalent.
- Training of Physicians and Representatives is equivalent. .
- Shelf life is equivalent. .
- The updated indications for use are substantially equivalent to . the Globus Revere Stabilization System (K100788).
- . The Cobalt-28 Chromium-6 Molybdenum utilized in the 500 and 600mm straight rods is equivalent to the CoCr rods in the Globus Revere Stabilization System (K100788).
- Mechanical testing performed to applicable ASTM standards demonstrating substantial equivalence.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
· Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 7, 2014
Innovasis. Incorporated Mr. Marshall C. McCarty Director, OA/RA 614 East 3900 South Salt Lake City. Utah 84107
Re: K140238
Trade/Device Name: Excella III-D® Spinal Deformity System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH, KWP, KWQ Dated: April 3, 2014 Received: April 4, 2014
Dear Mr. McCarty:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
5
Page 2 - Mr. Marshall C. McCarty
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K140238
Device Name
Excella III-D& Spinal Deformity System
Indications for Use (Describe)
The Innovasis Excella III-D Spinal Deformity System, when used as a posterior pedicle screw system, is 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 of the thoracic, lumbar and sacral spine: Degenerative disc disease (DDD-defined as discogenic back pain with disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.
The Innovasis Excella III-D Spinal Deformity System, is also indicated for treatment of severe spondylolisthesis (Grades 3 & 4) of the LS-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fision. Levels of pedicle screw fixation for these patients are L3-sacrum/illium.
When used as a posterior non-pedicle screw fixation system, the Innovasis Excella III-D Spinal Deformity System is intended for the treatment of degenerative disc disease (DDD-defined as discogenic back pain with degeneration of the disc confirmed by history and radios), spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis, Schevermann's disease), fracture, pseudoarthrosis, tumor resection, and/or failed previous fusion. Overall levels of fixation are TI-sacrum/ilium.
When used as an anterolateral thoracolumbar system, the Innovasis Excella III-D Spinal Deformity System is intended for anterolateral screw fixation for the following indications: Degenerative disc disease (DDD-defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, and/or lordosis), fracture or dislocation of the thoracolumbar spine, pseudoarthrosis, turnor resection, and/or failed previous fusion. Levels of screw fixation are T8-L5.
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)
James P. Bertram 2014.05.06 17:24:05 -04'00'
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