AFFINITY ANTERIOR CERVICAL CAGE SYSTEM
FDA premarket approval P000028/S005 · decided 2004-06-18
Approval details
- PMA number
- P000028
- Supplement
- S005
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- AFFINITY ANTERIOR CERVICAL CAGE SYSTEM
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- Date received
- 2004-05-19
- Decision date
- 2004-06-18
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- MAX
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- APPROVAL FOR AN ALTERNATIVE SURGICAL TECHNIQUE IN WHICH THE REAMING STEP IS REMOVED FROM THE SURGICAL PROCEDURE.
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