AFFINITY ANTERIOR CERVICAL CAGE SYSTEM
FDA premarket approval P000028/S006 · decided 2004-08-24
Approval details
- PMA number
- P000028
- Supplement
- S006
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AFFINITY ANTERIOR CERVICAL CAGE SYSTEM
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- Date received
- 2004-07-30
- Decision date
- 2004-08-24
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- MAX
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- CHANGE OF STERILIZATION VALIDATION METHODS FOR THE AFFINITY ANTERIOR CERVICAL CAGE SYSTEM.
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