BAK INTERBODY FUSION SYSTEM
FDA premarket approval P950002/S006 · decided 1998-05-12
Approval details
- PMA number
- P950002
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BAK INTERBODY FUSION SYSTEM
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Applicant
- Zimmer Spine, Inc.
- Date received
- 1998-01-08
- Decision date
- 1998-05-12
- Days to decision
- 124 days
- Decision code
- APPR
- Product code
- MAX
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for a new manufacturing site for the BAK and BAK/Proximity implants, Riteway Precision Machine, Inc.
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