BAK VISTA INTERBODY FUSION CAGE
FDA premarket approval P950002/S014 · decided 2004-07-01
Approval details
- PMA number
- P950002
- Supplement
- S014
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BAK VISTA INTERBODY FUSION CAGE
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Applicant
- Zimmer Spine, Inc.
- Date received
- 2004-01-21
- Decision date
- 2004-07-01
- Days to decision
- 162 days
- Decision code
- APPR
- Product code
- MAX
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL TO ADD THE FOLLOWING SIZES TO THE BAK VISTA DEVICE: 9X24 MM, 11X24 MM, 13X24 MM, 15X24 MM, 17X24 MM, 19X24 MM. 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
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