BAK INTERBODY FUSION SYSTEM
FDA premarket approval P950002 · decided 1996-09-20
Approval details
- PMA number
- P950002
- Trade name
- BAK INTERBODY FUSION SYSTEM
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Applicant
- Zimmer Spine, Inc.
- Date received
- 1995-01-17
- Decision date
- 1996-09-20
- Days to decision
- 612 days
- Decision code
- APRL
- Product code
- MAX
- Advisory committee
- Orthopedic
- Expedited review
- Yes
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR THE BAK INTERBODY FUSION SYSTEM WITH INSTRUMENTATION.
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