PRESTIGE® Cervical Disc
FDA premarket approval P060018/S004 · decided 2016-07-20
Approval details
- PMA number
- P060018
- Supplement
- S004
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- PRESTIGE® Cervical Disc
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Medtronic Sofamor Danek, Inc.
- Date received
- 2016-01-29
- Decision date
- 2016-07-20
- Days to decision
- 173 days
- Decision code
- APPR
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- Approval for 1) A 7-year post-approval study to evaluate the longer term safety and effectiveness of the PRESTIGE Cervical Disc. The study will involve the investigational and control patients from the pivotal investigational device exemption (IDE) study arm, as well as the patients who received the device as part of the continued access study (CAS) arm. Data will be collected at 3 years (36 months), 5 years (60 months), and 7 years (84 months) postoperatively for all patients. At each time poin
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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 |