BAK INTERBODY FUSION SYSTEM
FDA premarket approval P950002/S001 · decided 1997-07-22
Approval details
- PMA number
- P950002
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- BAK INTERBODY FUSION SYSTEM
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Applicant
- Zimmer Spine, Inc.
- Date received
- 1996-12-26
- Decision date
- 1997-07-22
- Days to decision
- 208 days
- Decision code
- APPR
- Product code
- MAX
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL TO INCLUDE THE LAPAROSCOPIC SURGICAL APPROACH IN THE LABELING FOR THE BAK INTERBODY FUSION SYSTEM.
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