BAK INTERBODY FUSION SYSTEM, BP/LORDOTIC DEVICE
FDA premarket approval P950002/S007 · decided 2002-05-01
Approval details
- PMA number
- P950002
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BAK INTERBODY FUSION SYSTEM, BP/LORDOTIC DEVICE
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Applicant
- Zimmer Spine, Inc.
- Date received
- 1999-02-11
- Decision date
- 2002-05-01
- Days to decision
- 1175 days
- Decision code
- APPR
- Product code
- MAX
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL TO ADD THE BP/LORDOTIC TO THE APPROVED PRODUCT LINE FOR THE BAK INTERBODY FUSION SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BP/LORDOTIC AND IS INDICATED FOR USE WITH AUTOGENOUS BONE GRAFT IN PATIENTS WITH DEGENERATIVE DISC DISEASE (DDD) AT THE L4-L5 AND/OR L5-S1 LEVELS. THESE DDD PATIENTS MAY ALSO HAVE UP TO GRADE I SPONDYLOLISTHESIS OR RETROLISTHESIS AT THE INVOLVED LEVEL(S). BP/LORDOTIC DEVICES ARE TO BE IMPLANTED VIA AN OPEN ANTERIOR OR LAPAROSCOPIC APPROA
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.