NUVASIVE ANTERIOR CERVICAL PLATE SYSTEM

{0}------------------------------------------------ K041447 py (1/2) 510(k) Premarket Notification Anterior Cervical Plate System NuVasive®, Incorporated # AUG 16, 2004 ### VII. 510(k) Summary In accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title of the Code of In accordance with the Sare 7 (21 CFR §807), and in particular §807.92, the following summary of safety and effectiveness information is provided: ### A. Submitted by Laetitia Bernard Director of Regulatory Affairs and Quality Assurance NuVasive, Incorporated 10065 Old Grove Road San Diego, CA 92131 Telephone: (858) 527-1918 Date Prepared: May 28, 2004. #### B. Device Name | Trade or Proprietary Name: | NuVasive Anterior Cervical Plate System | |----------------------------|----------------------------------------------| | Common or Usual Name: | Spinal Fixation System | | Classification Name: | Spinal Intervertebral Body Fixation Orthosis | #### C. Predicate Devices The subject device is substantially equivalent to similar previously cleared devices. #### D. Device Description The NuVasive Anterior Cervical Plate System consists of a variety of plates and screws. Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient. #### E. Intended Use The NuVasive Anterior Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The system is to provide immobilization and stabilization of cervical 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 cervical spine: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, failed previous fusions, and/or spinal stenosis. {1}------------------------------------------------ c41447 pg(2/2) NuVasive®, Incorporated # F. Comparison to Predicate Devices As was established in this submission, the subject device is substantially equivalent to other As was established in the sey for commercial distribution in the United States. Engineering drawings, labeling, and mechanical testing have demonstrated that the subject Englicoling drawings, laooing, and me me me me me me many of design, device is substantially of court and its for use, and such other characteristics as may be associated with the manufacture of any medical device. ## G. Summary of Non-Clinical Tests Mechanical testing was presented. ## H. Summary of Clinical Tests (Not Applicable). {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three wing-like shapes, representing the department's mission to protect the health of all Americans and provide essential human services. ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 1 6 2004 Ms. Laetitia Bernard Mis. Executive of Regulatory Affairs and Quality Assurance NuVasive, Incorporated 10065 Old Grove Road San Diego, California 92131 Re: K041447 Ro+1++7 Trade/Device Name: Nuvasive Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: May 28, 2004 Received: June 1, 2004 Dear Ms Bernard: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 310(t) premium is substantially equivalent (for the indications ferenced above and nave determined ly marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to commerce proc to May 20, 1976, the enacement with the provisions of the Federal Food, Drug, devices mat have occh recalismou in accera approval of a premarket approval application (PMA). and Cosmelle Act (Act) market the device, subject to the general controls provisions of the Act. The 1 ou may, mercrore, thanket the act include requirements for annual registration, listing of general controls provisions 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 If your device is classified (600 above) of ols. Existing major regulations affecting your device can Inay oc subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in ther announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean i lease be advisou that I Driver and that your device complies with other requirements of the Act that I Dri has made a avoid regulations administered by other Federal agencies. You must of any I edelar statutes and registments, including, but not limited to: registration and listing (21 comply will an the Hev 31 CFR Part 801); good manufacturing practice requirements as set CI K I art 607), adoling (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 - Ms. Laetitia Bernard This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin manag of substantial equivalence of your device to a legally premarket notineation: The PDF intembers on the sour 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 If you ucsire specific advice 10. Jour 2011) 594-4659. Also, please note the regulation entitled, Connact the Oriece of Commarket notification" (21CFR Part 807.97). You may obtain Missianding of reference to promezionsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, Internet and address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Mark A. Mulhern 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 {4}------------------------------------------------ A. Indications for Use K041447 510(k) Number (if known): Device Name: NuVasive Anterior Cervical Plate System Indications for Use: The NuVasive Anterior Cervical Plate System is intended for anterior interbody fixation The Nu vasive haterior Octrical tais to provide immobilization and stabilization of of the cervical segments in skeletally mature patients as an adjunct to fusion in the cervical spinal segments in sherewing instabilities or deformities of the cervical spine: degenerative disc disease (as defined by neck pain of discogenic origin with spine. degenerative also confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), tumors, deformity (defined as spondylomsmosis, tradina (no), pseudoarthrosis, failed previous fusions, and/or spinal stenosis. for Mark N. Milheim ral, Restorative, Division of Gene and Neurological Devices 510(k) Number K091447 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)