Prestige Cervical Disc System
FDA premarket approval P060018 · Prosthesis, intervertebral disc
PMA numberP060018
Approval
- Applicant
- Medtronic Sofamor Danek, Inc.
- Received
- May 19, 2006
- Decision date
- July 16, 2007 (APWD)
- Supplements
- 5, latest August 11, 2016
- Product code
- MJO – Prosthesis, Intervertebral Disc
Approval order 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.