VERTELINK KOBRA SPINAL FIXATION SYSTEM

{0}------------------------------------------------ 2 SI 1-y Premarket Notification - Vertelink KOBRA DEC 1 2 2003 Image /page/0/Picture/3 description: The image shows a close-up of a document with the word "ertelink" prominently displayed. The text is in a bold, sans-serif font and appears to be part of a larger title or heading. The background is dark, contrasting with the white text, and there are some blurred or obscured areas around the edges of the text. 30 Hughes, Suite 206 Irvine, CA 92618 Phone 949-455-1128 WWW.vertelink com ## SUMMARY Submitter's name: Address: Name of contact person: Phone: Fax number: Vertelink corporation 30 Hughes, Suite 206 Irvine, CA 92618 949-455-1128 949-455-1158 Grea Holland Requlatory Specialists, Inc 3722 Ave. Sausalito Irvine, CA 92606 Phone: 949-262-0411 fax: 949-552-2821 Date the summary was prepared: July 2, 2003 Name of the device: Trade or proprietary name: Common or usual name: Classification name: Vertelink KOBRA™ Fixation System Vertelink KOBRA™ Fixation System Spinal Fixation System Spinal Intervertebral Body Fixation Orthosis (per 21 CFR section 888.3060) Spondylolisthesis Spinal Fixation Device System (per 21 CFR section 888.3070) Pedicle Screw Spinal System (per 21 CFR section 888.3070) The legally marketed device to which we are claiming equivalence [807.92(a)(3)]: CD HORIZON® Spinal System, manufactured by Medtronic Sofamor Danek, Inc. USA. The clearance number is K030932. Description of the device: The Vertelink KOBRA™ Spinal Fixation System is designed to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the acute and pationic instabilities or deformities of the lumbar spine, spinal tumor and failed previous fusions. It can be used in either percutaneous or open surgery procedures. {1}------------------------------------------------ The system is composed of titanium pedicle screws and rods that are implanted in posterior manner either during an open surgical procedure or percutaneously using minimally invasive techniques. In both open and percuataneous techniques the pedicle screws are placed under fluoroscopic guidance and in the percutaneous technique the pathway between the screw portals is cannulated using minimally invasive techniques. In the percutaneous fixation technique, six (6) small holes (no greater than 1.2cm) are used to introduce the construct. Both open and percutaneous techniques use accessories and tools to provide effective placement. Indications: - Degenerative disc disease (as defined by back pain of discogenic 1) origin with degeneration of the disc confirmed by patient history and radiographic studies) - Spinal stenosis 2) - 3) Spondylolisthesis - Spinal deformities 4) - 5) Fractures - Pseudarthrosis ର) - Tumor resection 7) - Failed previous Fusion 8) When used as Fixation system the multiaxial screw components are also indicated for skeletally mature patients: - a) Having severe spondylolisthesis (grade 3 or 4) of the L5-S1 vertebral joint. - b) Who are receiving fusion using authogeneous bone graft only - c) Who are having the device fixed or attached to the lumbar or sacral spine (L3 and bellow) - d) Who are having the device removed after the development of solid fusion mass. Summary of the technological characteristics of our device compared to the predicate device: As can be seen in the Comparison section, the Vertelink KOBRA™ Fixation System and CD HORIZON® Spinal System have similar technological characteristics and are equivalent. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, representing the department's mission to protect the health of all Americans. Public Health Service DEC 1 2 2003 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Vertelink Corporation C/o Mr. Greg Holland Regulatory Specialists, Inc. 3722 Avenue Sausalito Irvine, California 92606 Re: K032102 Trade/Device Name: Vertelink KOBRA" Spinal Fixation System Regulation Number: 21 CFR 888.3060, 21 CFR 888.3070 Regulation Name: Spinal intervertebral body fixation orthosis, Pedicle screw spinal system Regulatory Class: II Product Code: KWQ, MNH, MNH, MNI Dated: October 14, 2003 Received: October 15, 2003 Dear Mr. Holland: 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 I'DA'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 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. {3}------------------------------------------------ Page 2 - Mr. Greg Holland This letter will allow you to begin marketing your device as described in your Scction 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" (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/cdrh/dsma/dsmamain.html Sincerely yours, Mark N. Millman Celia 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 {4}------------------------------------------------ Page koszloz si 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ Device Name: Vertelink KOBRA™ Fixation System Indications For Use: 1) Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) Spinal stenosis, 3) Spondylolisthesis, 4) Spinal deformities, 5) Fractures, 6) Pseudarthrosis,7) Tumor resection, 8) Failed previous Fusion. When used as Fixation system the multiaxial screw components are also indicated for skeletally mature patients: a. Having severe spondylolisthesis (grade 3 or 4) of the L5-S1 vertebral joint, b. Who are receiving fusion using authogeneous bone graft only, c. Who are having the device fixed or attached to the lumbar or sacral spine (L.3 and below), d. Who are having the device removed after the development of solid fusion mass. | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | |--------------------------------------------------------------------------| |--------------------------------------------------------------------------| Concurrence of CDRH, Office of Device Evaluation (ODE) for Mark A Milkus Division m-Off) Division c eral, Restorative and Neuro gical Devices ) Nu K032102 Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96)