PMA P950002S007

Device: BAK INTERBODY FUSION SYSTEM, BP/LORDOTIC DEVICE
Applicant: Zimmer Spine, Inc.
PMA number: P950002
Supplement: S007
Product code: MAX
Decision date: 2002-05-01
Generic name: Intervertebral fusion device with bone graft, lumbar
Approval order 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 APPROACH. DDD IS DEFINED AS DISCOGENIC BACK PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY HISTORY AND RADIOGRAPHIC STUDIES. THESE PATIENTS SHOULD BE SKELETALLY MATURE AND HAVE HAD SIX MONTHS OF NON-OPERATIVE TREATMENT.

Current openFDA PMA Record#

Device: BAK INTERBODY FUSION SYSTEM, BP/LORDOTIC DEVICE
Applicant: Zimmer Spine, Inc.
PMA number: P950002
Supplement: S007
Product code: MAX
Generic name: Intervertebral fusion device with bone graft, lumbar
Decision date: 2002-05-01
Decision code: APPR
Date received: 1999-02-11
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order 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 APPROACH. DDD IS DEFINED AS DISCOGENIC BACK PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY HISTORY AND RADIOGRAPHIC STUDIES. THESE PATIENTS SHOULD BE SKELETALLY MATURE AND HAVE HAD SIX MONTHS OF NON-OPERATIVE TREATMENT.