PMA P950002S001
- Device
- BAK INTERBODY FUSION SYSTEM
- Applicant
- Zimmer Spine, Inc.
- PMA number
- P950002
- Supplement
- S001
- Product code
- MAX
- Decision date
- 1997-07-22
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Approval order statement
- APPROVAL TO INCLUDE THE LAPAROSCOPIC SURGICAL APPROACH IN THE LABELING FOR THE BAK INTERBODY FUSION SYSTEM.
Current openFDA PMA Record#
- Device
- BAK INTERBODY FUSION SYSTEM
- Applicant
- Zimmer Spine, Inc.
- PMA number
- P950002
- Supplement
- S001
- Product code
- MAX
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Decision date
- 1997-07-22
- Decision code
- APPR
- Date received
- 1996-12-26
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL TO INCLUDE THE LAPAROSCOPIC SURGICAL APPROACH IN THE LABELING FOR THE BAK INTERBODY FUSION SYSTEM.