PMA P950002S005
- Device
- BAK INTERBODY FUSION SYSTEM
- Applicant
- Zimmer Spine, Inc.
- PMA number
- P950002
- Supplement
- S005
- Product code
- MAX
- Decision date
- 1998-02-06
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Approval order statement
- Approval for an additional packaging configuration and gamma sterilization for the BAK and BAK/Proximity implants.
Current openFDA PMA Record#
- Device
- BAK INTERBODY FUSION SYSTEM
- Applicant
- Zimmer Spine, Inc.
- PMA number
- P950002
- Supplement
- S005
- Product code
- MAX
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Decision date
- 1998-02-06
- Decision code
- APPR
- Date received
- 1997-12-15
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for an additional packaging configuration and gamma sterilization for the BAK and BAK/Proximity implants.