BAK/L INTERBODY FUSION SYSTEM
FDA premarket approval P950002/S008 · decided 1999-12-20
Approval details
- PMA number
- P950002
- Supplement
- S008
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BAK/L INTERBODY FUSION SYSTEM
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Applicant
- Zimmer Spine, Inc.
- Date received
- 1999-10-22
- Decision date
- 1999-12-20
- Days to decision
- 59 days
- Decision code
- APPR
- Product code
- MAX
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for the additional sizes to the BAK product line.
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