PMA P950002S003
- Device
- BAK INTERBODY FUSION SYSTEM
- Applicant
- Zimmer Spine, Inc.
- PMA number
- P950002
- Supplement
- S003
- Product code
- MAX
- Decision date
- 1997-10-15
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Approval order statement
- Approval for the BAK/RLP (Reduced Lateral Profile) implant configuration of the BAK Interbody Fusion System.
Current openFDA PMA Record#
- Device
- BAK INTERBODY FUSION SYSTEM
- Applicant
- Zimmer Spine, Inc.
- PMA number
- P950002
- Supplement
- S003
- Product code
- MAX
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Decision date
- 1997-10-15
- Decision code
- APPR
- Date received
- 1997-03-19
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the BAK/RLP (Reduced Lateral Profile) implant configuration of the BAK Interbody Fusion System.