BAK/PROXIMITY(TM) INTERBODY FUSION SYSTEM
FDA premarket approval P950002/S009 · decided 2001-04-03
Approval details
- PMA number
- P950002
- Supplement
- S009
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- BAK/PROXIMITY(TM) INTERBODY FUSION SYSTEM
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Applicant
- Zimmer Spine, Inc.
- Date received
- 2001-03-08
- Decision date
- 2001-04-03
- Days to decision
- 26 days
- Decision code
- APPR
- Product code
- MAX
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR A CHANGE TO THE LABELING OF THE BAK INTERBODY FUSION SYSTEM ADDING A PRECAUTION STATEMENT (IE., THE BAK/PROXIMITY DEVICE IS TO BE USED ONLY IN CONJUNCTINO WITH A STANDARD BAK DEVICE. THE SAFETY AND EFFECTIVENESS OF THE BAK/PROXIMITY DEVICE HAS NOT BEEN ESTABLISHED WHEN USED OTHERWISE.) EFFECTIVE APRIL 1, 2001.
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