EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM

{0}------------------------------------------------ 510(k) Summary of Safety & Effectiveness K9739223 This 510(k) Summary of Safety and Effectiveness for the EBI SpineLink™ Anterior Cervical Spinal System is provided as required per Section 513(1)(3) of the Food, Drug, and Cosmetic Act. - Electro-Biology, Inc. 1. Submitter: 6 Upper Pond Road Parsippany, NJ 07054 Contact Person: Jon Caparotta Telephone: (973) 299-9022 Date prepared: October 14, 1997 EBI SpineLink™ Anterior Cervical Spinal System 2. Proprietary Name: Common Name: Spinal Fixation Device Classification Names: Spinal Intervertebral Body Fixation Orthosis - 3. Predicate or legally marketed devices that are substantially equivalent: - · The EBI Anterior Cervical Spine System Electro-Biotogy, Inc. - · The Anterior Cervical Plate System Sofamor Danek - · The Synthes® Cervical Spine Locking Plate Synthes® Spine - 4. Description of the device: The EBI SpineLink™ Anterior Cervical Spinal System is an anterior cervical spinal fixation system. - 5. Intended Use: The EBI SpineLink™ Anterior Cervical Spinal System is intended for anterior interbody screw fixation of the cervical spine at levels C3-C7. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, or scoliosis) pseudanthrosis, and/or failed previous fusions. WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. {1}------------------------------------------------ - 6. Materials: The components of the system are manufactured from Ti-6AI-4V ELI per ASTM F136. - 7. Comparison of the technological characteristics of the device to predicate devices: There are no significant differences between EBI SpineLink™ Anterior Cervical Spinal System and other currently marketed spinal systems. The EBI SpineLink Anterior Cervical Spinal System uses links instead of plates for the same intended use in a similar construct. It is substantially equivalent* to the predicate devices in regards to intended use, materials and function. Bench testing comparing the system to a predicate system demonstrated that the device complies with applicable standards and meets all of its functional requirements. "Any states to whether the product can be lawfully a december of sidenced equivalent and is not intended to be pressed as an admission or any other you of cvidence in patent infringencer. Establishment Registration and Premarker Notification Procedures, Final Regulation, Preamble, August 23, 1977. FR 42520 (Docket No. 76N-0355.)) {2}------------------------------------------------ Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 1 3 1998 Mr. Jon Caparotta Manager, Requlatory Affairs · Electro-Biology, Inc. (EBI) 6 Upper Pond Road Parsippany, New Jersey 07054 Re : K973923 EBI SpineLink™ Anterior Cervical Spinal System Requlatory Class: II Product Code: KWQ Dated: October 14, 1997 Received: October 15, 1997 Dear Mr. Caparotta: We have reviewed your Section 510(k) notification of intent to market the device system referenced above and we have determined the device system is substantially equivalent (for the indications for use stated in the enclosure) to device systems marketed in interstate commerce prior to May 28, 1976 or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act You may, therefore, market your device system subject (Act). to the general controls provisions of the Act and the limitations identified below. 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. Note that labeling or otherwise promoting this device system for pedicular screw fixation/attachment would cause the device system to be adulterated under 501(f)(1) of the Act. FDA identifies that any device system, if intended for use in pedicular screw fixation/attachment, except for some limited ... indications, would be found not substantially equivalent and would be a class III device under Section 513 (f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing. Accordingly: - You may not label or in any way promote this device 1. system for pedicular screw attachment to, or fixation of the cervical, thoracic or lumbar vertebral column. Therefore, in order to prevent off-label promotion, the package insert must include the following statement, "WARNING: This device system is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine."; {3}------------------------------------------------ - All labeling for this device system, including the 2. package label, must state that there are labeling limitations. The package insert must prominently state that the device system is intended for the specific use(s) described in the enclosure only; and - Pedicular screw fixation/attachment to the cervical, 3 . thoracic or lumbar vertebral column, except for limited indications, of any device system is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulations under 21 CFR, Part 812. All users of the device system for pedicular screw fixation/attachment must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) prior to conducting an investigation. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Requlations. FDA advises that the use of the subject device system and/or device components with any other device components but those identified in this 510(k) would require submission of a new 510 (k) providing documentation of design, material, and labeling compatibility between the device components. Mechanical testing of a spinal system consisting of the subject device components and other device components, whether yours or other manufacturers', may also be required. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. {4}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, C. M. Whitten, Ph.D., M.D. Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ## Statement of Indications for Use: The EBI SpineLink™ Anterior Cervical Spinal System is intended for anterior interbody screw fixation of the cervical spine at levels C3-C7. The System is indicated fogense in the temporary stabilization of the anterior spine during the development of cervical spinal fusions with degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, or scoliosis), pseudarthrosis, and/or failed previous fusions. WARNING: This device is not approved for screw attachments of the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. **Prescription Use** **(Per 21 CFR 801.109)** vision of General Restorative Devic 510(k) Numbe