(99 days)
The EBI Omega21 Spinal Fixation System is a non-cervical spinal fixation device intended for use as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and or lordosis), tumor, stenosis, pseudoarthrosis, and failed previous fusion.
The EBI® Omega21 Spinal Fixation System is a spinal fixation device that utilizes rods, screws, couplers and hooks. This submission is for the modification to the Indications for Use.
The provided document is a 510(k) summary for a spinal fixation system, not a study evaluating an AI/ML device. Therefore, it does not contain information related to acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study methodologies typically associated with AI/ML device evaluations.
The document is primarily focused on demonstrating substantial equivalence of the EBI® Omega21™ Spinal Fixation System to previously marketed predicate devices, as required for FDA clearance. It describes the device, its intended use, materials, and compares its technological characteristics to existing devices.
Therefore, I cannot extract the requested information as it is not present in the provided text.
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AUG - 6 2003
K031354 Page 1 of 2
510(k) Summary
This 510(k) Summary for the EBI® Omega21™ Spinal Fixation System is provided as required per Section 513(3) of the Food, Drug and Cosmetic Act.
Contact Person: Frederic Testa, RAC 1. Submitter: EBI, L.P. Telephone: (973) 299-9300, ext.2208 100 Interpace Parkway Parsippany, NJ 07054
Date prepared: July 14, 2003
| 2. Proprietary Name: | EBI® Omega21™ Spinal Fixation System |
|---|---|
| Common Name: | Spinal Fixation Device |
| Classification Names: | Spondylolisthesis Spinal Fixation Device System |
| Spinal Intervertebral Body Fixation Orthosis | |
| Spinal Interlaminal Fixation Orthosis |
3. Predicate or legally marketed devices that are substantially equivalent:
- Spinal Concepts BacFix Spinal Fixation System (K013887) .
- Sofamor Danek CD Spinal System (K964159) .
- Sofamor Danek Townley Pedicle Screw Plating System (K983706) ●
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- Description of the device: The EBI® Omega21 Spinal Fixation System is a spinal fixation device that utilizes rods, screws, couplers and hooks. This submission is for the modification to the Indications for Use.
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- Intended Use: The EBI® SpineLink® II Spinal Fixation System is a non-cervical spinal fixation device intended for use as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterolateral fixation system.
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Pedicle screw fixation is limited to skeletally mature patients. The device is indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and or lordosis), tumor, stenosis, pseudoarthrosis, and failed previous fusion.
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- Materials: The components of the System are manufactured from titanium alloy (Ti-6A1-4V ELI) per ASTM F136.
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- Comparison of the technological characteristics of the device to predicate devices: There are no significant differences between the proposed EBI® Omega21™ Spinal Fixation System and the currently marketed EBI Omega21 Spinal Fixation System. It is substantially equivalent* to the predicate devices in regards to intended use, materials, and function.
*Any statement made in conjunction with this submission regarding a determination of substantial equivalence to any other product is intended only to relate to whether the product can be lawfully marketed without pre-market approval or reclassification and is not interpreted as an admission or any other type of evidence in patent infringement litigation. JEstablishment Registration and Premarket Notification Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355.)]
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Image /page/2/Picture/1 description: The image shows a circular logo with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" in a circular arrangement. The central symbol consists of three curved lines stacked on top of each other, resembling a stylized bird or abstract design. The logo appears to be a seal or emblem, possibly representing a government agency or organization related to health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 6 2003
Mr. Frederic Testa, RAC Senior Regulatory Affairs Specialist EBI, L.P. 100 Interpace Parkway Parsippany, NJ 07054
Re: K031354
Trade/Device Name: EBI Omega21 Spinal Fixation System Regulation Number: 21 CFR 888.3050, 888.3060, 888.3070 Regulation Name: Spinal interlaminal fixation orthosis, Spinal intervertebral body fixation Orthosis, Pedicle screw spinal system Regulatory Class: III Product Code: KWP, KWQ, MNH, MNI, NKB Dated: July 14, 2003 Received: July 15, 2003
Dear Mr. Testa:
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 listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
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Page 2 - Mr. Frederic Testa, RAC
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. 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 (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
forCelia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Statement of Indications for Use
Page 1 of of los
510(k) Number (if known): K031354
Device Name: EBI® Omega21™ Spinal Fixation System
Indications For Use:
The EBI Omega21 Spinal Fixation System is a non-cervical spinal fixation device intended for use as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and or lordosis), tumor, stenosis, pseudoarthrosis, and failed previous fusion.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K031354
N/A