PMA P950002S006
- Device
- BAK INTERBODY FUSION SYSTEM
- Applicant
- Zimmer Spine, Inc.
- PMA number
- P950002
- Supplement
- S006
- Product code
- MAX
- Decision date
- 1998-05-12
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Approval order statement
- Approval for a new manufacturing site for the BAK and BAK/Proximity implants, Riteway Precision Machine, Inc.
Current openFDA PMA Record#
- Device
- BAK INTERBODY FUSION SYSTEM
- Applicant
- Zimmer Spine, Inc.
- PMA number
- P950002
- Supplement
- S006
- Product code
- MAX
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Decision date
- 1998-05-12
- Decision code
- APPR
- Date received
- 1998-01-08
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a new manufacturing site for the BAK and BAK/Proximity implants, Riteway Precision Machine, Inc.