PRESTIGE CERVICAL DISC SYSTEM
FDA premarket approval P060018 · decided 2007-07-16
Approval details
- PMA number
- P060018
- Trade name
- PRESTIGE CERVICAL DISC SYSTEM
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Medtronic Sofamor Danek, Inc.
- Date received
- 2006-05-19
- Decision date
- 2007-07-16
- Days to decision
- 423 days
- Decision code
- APWD
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- Yes
- Location
- Memphis, TN
- 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],
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Grafton™ DBM; Grafton Plus™ DBM Paste; Magnifuse™ Bone Graft (K251193) | Medtronic Sofamor Danek, Inc. | 2025-06-12 |
| Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft Granules (K243706) | Medtronic Sofamor Danek, Inc. | 2025-01-17 |
| Robotic Graft Delivery Instruments (K230716) | Medtronic Sofamor Danek, Inc. | 2023-07-18 |
| MASTERGRAFT MATRIX EXT; MASTERGRAFT PUTTY, MASTERGRAFT STRIP (K141824) | Medtronic Sofamor Danek, Inc. | 2014-09-05 |
| DIVERGENCE MINI-PLATE ANTERIOR CERVICAL FUSION SYSTEM (K140417) | Medtronic Sofamor Danek, Inc. | 2014-07-09 |
| CD HORIZON SPINAL SYSTEM (K140449) | Medtronic Sofamor Danek, Inc. | 2014-03-25 |
| CLYDESDALE SPINAL SYSTEM (K132897) | Medtronic Sofamor Danek, Inc. | 2013-12-11 |
| CRESCENT SPINAL SYSTEM (K133216) | Medtronic Sofamor Danek, Inc. | 2013-11-22 |