PMA P950002S011

Device: BAK VISTA INTERBODY FUSION DEVICE
Applicant: Zimmer Spine, Inc.
PMA number: P950002
Supplement: S011
Product code: MAX
Decision date: 2003-07-08
Generic name: Intervertebral fusion device with bone graft, lumbar
Approval order statement: APPROVAL TO ADD 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 L2-S1 SPINAL LEVELS. THESE DDD PATIENTS MAY ALSO HAVE UP TO GRADE I SPONDYLOLISTHESIS OR RETROLISTHESIS AT THE INVOLVED LEVEL(S). BAK DEVICES ARE TO BE IMPLANTED VIA AN OPEN ANTERIOR OR POSTERIOR 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 VISTA INTERBODY FUSION DEVICE
Applicant: Zimmer Spine, Inc.
PMA number: P950002
Supplement: S011
Product code: MAX
Generic name: Intervertebral fusion device with bone graft, lumbar
Decision date: 2003-07-08
Decision code: APPR
Date received: 2002-08-29
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL TO ADD 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 L2-S1 SPINAL LEVELS. THESE DDD PATIENTS MAY ALSO HAVE UP TO GRADE I SPONDYLOLISTHESIS OR RETROLISTHESIS AT THE INVOLVED LEVEL(S). BAK DEVICES ARE TO BE IMPLANTED VIA AN OPEN ANTERIOR OR POSTERIOR 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.