VISTA LORDOTIC INTERBODY FUSION CAGE
FDA premarket approval P950002/S013 · decided 2004-01-29
Approval details
- PMA number
- P950002
- Supplement
- S013
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VISTA LORDOTIC INTERBODY FUSION CAGE
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Applicant
- Zimmer Spine, Inc.
- Date received
- 2003-12-24
- Decision date
- 2004-01-29
- Days to decision
- 36 days
- Decision code
- APPR
- Product code
- MAX
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR THE VISTA LORDOTIC DEVICE TO THE APPROVED PRODUCT LINE FOR THE BAK INTERBODY FUSION SYSTEM. THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME VISTA LORDOTIC AND IS INDICATED FOR USE WITH AUTOGENOUS BONE GRAFT IN PATIENTS WITH DEGENERATIVE DISC DISEASE (DDD) AT ONE OR TWO CONTINUOUS LEVELS FROM L4-L5 AND/OR L5-S1. THESE DDD PATIENTS MAY ALSO HAVE UP TO GRADE I SPONDYLOLISTHESIS OR RETROLISTHESIS AT THE INVOLVED LEVEL(S). DDD IS DEFINED AS DISCOGENIC BACK PAIN WITH DEGENERATION OF THE
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