Prosthesis, Intervertebral Disc
Basic Information
- Device Name
- Prosthesis, Intervertebral Disc
- Trade Name
- PRESTIGE CERVICAL DISC SYSTEM
- PMA Number
- P060018
- Device Class
- FDA Class 3
- Product Code
- MJO
- Generic Name
- Prosthesis, intervertebral disc
- Medical Specialty
- Unknown
- Advisory Committee
- Orthopedic
- Decision
- Approved (Withdrawn)
- Decision Code
- APWD
- Decision Date
- July 16, 2007
- Date Received
- May 19, 2006
- Expedited Review
- Y
- Docket Number
- 07M-0289
Advisory Committee Statement
APPROVAL FOR THE PRESTIGE CERVICAL DISC SYSTEM. THIS DEVICE IS INDICATED FOR RECONSTRUCTION OF THE DISC FROM C3-C7 FOLLOWING SINGLE-LEVEL DISCECTOMY FOR INTRACTABLE RADICULOPATHY AND/OR MYELOPATHY. THE PRESTIGE DEVICE IS IMPLANTED VIA AN OPEN ANTERIOR APPROACH. INTRACTABLE RADICULOPATHY AND/OR MYELOPATHY SHOULD PRESENT WITH AT LEAST ONE OF THE FOLLOWING ITEMS PRODUCING SYMPTOMATIC NERVE ROOT AND/OR SPINAL CORD COMPRESSION WHICH IS DOCUMENTED BY PATIENT HISTORY (E.G., PAIN [NECK AND/OR ARM PAIN], FUNCTIONAL DEFICIT, AND/OR NEUROLOGICAL DEFICIT), AND RADIOGRAPHIC STUDIES (E.G., CT, MRI, X-RAYS, ETC.): 1) HERNIATED DISC, AND/OR 2) OSTEOPHYTE FORMATION.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MJO | Prosthesis, Intervertebral Disc | FDA class 3 | Unknown |