AFFINITY ANTERIOR CERVICAL CAGE SYSTEM
FDA premarket approval P000028/S003 · decided 2003-07-02
Approval details
- PMA number
- P000028
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- AFFINITY ANTERIOR CERVICAL CAGE SYSTEM
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- Date received
- 2002-11-08
- Decision date
- 2003-07-02
- Days to decision
- 236 days
- Decision code
- APPR
- Product code
- MAX
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- APPROVAL FOR ADDITIONAL MANUFACTURING FACILITY TO PERFORM PACKAGING FOR TERMINAL STERILIZATION. THE FACILITY IS LOCATED AT MEDTRONIC SOFAMOR DANEK, WARSAW, INDIANA. ALSO, APPROVAL FOR AN ADDITIONAL STERILIZATION FACILITY LOCATED AT IBA STERIGENICS, WESTERVILLE, OHIO AND AN ADDITIONAL TESTING FACILITY LOCATED AD NAMSA, NORTHWOOD, OHIO.
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|---|---|---|
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| Infinity™ OCT System (K253129) | Medtronic Sofamor Danek USA, Inc. | 2025-10-24 |
| CD Horizon™ Spinal System (K253335) | Medtronic Sofamor Danek USA, Inc. | 2025-10-24 |