BAK VISTA INTERBODY FUSION DEVICE
FDA premarket approval P950002/S011 · decided 2003-07-08
Approval details
- PMA number
- P950002
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BAK VISTA INTERBODY FUSION DEVICE
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Applicant
- Zimmer Spine, Inc.
- Date received
- 2002-08-29
- Decision date
- 2003-07-08
- Days to decision
- 313 days
- Decision code
- APPR
- Product code
- MAX
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL TO ADD THE BAK VISTA INTERBODY FUSION DEVICE, WHICH IS MANUFACTURED FROM 65% PEEK OPTIMA AND 35% TOHO BESFIGHT C6-UH CARBON FIBER, TO THE APPROVED PRODUCT LINE FOR THE BAK INTERBODY FUSION SYSTEM. THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME BAK VISTA INTERBODY FUSION DEVICE AND IS INDICATED FOR USE WITH AUTOGENOUS BONE GRAFT IN PATIENTS WITH DEGENERATIVE DISC DISEASE (DDD) AT THE L2-S1 SPINAL LEVELS. THESE DDD PATIENTS MAY ALSO HAVE UP TO GRADE I SPONDYLOLISTHESIS OR RETROLISTHESIS
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