BAK INTERBODY FUSION SYSTEM
FDA premarket approval P950002/S005 · decided 1998-02-06
Approval details
- PMA number
- P950002
- Supplement
- S005
- Supplement type
- Real-Time Process
- Supplement reason
- Process 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
- 1997-12-15
- Decision date
- 1998-02-06
- Days to decision
- 53 days
- Decision code
- APPR
- Product code
- MAX
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for an additional packaging configuration and gamma sterilization for the BAK and BAK/Proximity implants.
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