NUVASIVE ANTERIOR CERVICAL PLATE SYSTEM

K041447 · Nuvasive, Inc. · KWQ · Aug 16, 2004 · Orthopedic

Device Facts

• Record ID: K041447
• Device Name: NUVASIVE ANTERIOR CERVICAL PLATE SYSTEM
• Applicant: Nuvasive, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Aug 16, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

NuVasive Anterior Cervical Plate System consists of metallic plates and screws for anterior cervical spine fixation. System provides immobilization and stabilization of cervical spinal segments as an adjunct to fusion. Components are rigidly locked in various configurations to accommodate patient-specific pathology and anatomy. Used by surgeons in clinical settings to treat acute and chronic instabilities or deformities. Device provides structural support to the cervical spine, facilitating fusion and potentially reducing pain and restoring stability in patients with degenerative, traumatic, or neoplastic conditions.

Clinical Evidence

No clinical data.

Technological Characteristics

System consists of plates and screws for spinal intervertebral body fixation. Components allow for rigid locking in multiple configurations. Materials and specific standards are not detailed in the provided text.

Indications for Use

Indicated for skeletally mature patients requiring anterior interbody fixation of the cervical spine for immobilization and stabilization as an adjunct to fusion. Conditions include degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), tumors, deformity (kyphosis, lordosis, scoliosis), pseudoarthrosis, failed previous fusions, and spinal stenosis.

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

Submission Summary (Full Text)

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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: [phone] 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.

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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).

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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.

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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 [phone] 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

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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)