BAK INTERBODY FUSION SYSTEM
FDA premarket approval P950002/S003 · decided 1997-10-15
Approval details
- PMA number
- P950002
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BAK INTERBODY FUSION SYSTEM
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Applicant
- Zimmer Spine, Inc.
- Date received
- 1997-03-19
- Decision date
- 1997-10-15
- Days to decision
- 210 days
- Decision code
- APPR
- Product code
- MAX
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for the BAK/RLP (Reduced Lateral Profile) implant configuration of the BAK Interbody Fusion System.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.