- Device
- AFFINITY ANTERIOR CERVICAL CAGE SYSTEM
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- PMA number
- P000028
- Supplement
- S005
- Product code
- MAX
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Decision date
- 2004-06-18
- Decision code
- APPR
- Date received
- 2004-05-19
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR AN ALTERNATIVE SURGICAL TECHNIQUE IN WHICH THE REAMING STEP IS REMOVED FROM THE SURGICAL PROCEDURE.