Bak Interbody Fusion System
FDA premarket approval P950002 · Intervertebral fusion device with bone graft, lumbar
PMA numberP950002
Approval
- Applicant
- Zimmer Spine, Inc.
- Received
- January 17, 1995
- Decision date
- September 20, 1996 (APRL)
- Supplements
- 13, latest July 1, 2004
- Product code
- MAX – Intervertebral Fusion Device With Bone Graft, Lumbar
Approval order statement
APPROVAL FOR THE BAK INTERBODY FUSION SYSTEM WITH INSTRUMENTATION.