PMA P950002S013

Device: VISTA LORDOTIC INTERBODY FUSION CAGE
Applicant: Zimmer Spine, Inc.
PMA number: P950002
Supplement: S013
Product code: MAX
Decision date: 2004-01-29
Generic name: Intervertebral fusion device with bone graft, lumbar
Approval order 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 DISC CONFIRMED BY HISTORY AND RADIOGRAPHIC STUDIES. THESE PATIENTS SHOULD BE SKELETALLY MATURE AND HAVE HAD SIX MONTHS OF NON-OPERATIVE TREATMENT. VISTA LORDOTIC DEVICES ARE TO BE IMPLANTED VIA AN OPEN ANTERIOR APPROACH.

Current openFDA PMA Record#

Device: VISTA LORDOTIC INTERBODY FUSION CAGE
Applicant: Zimmer Spine, Inc.
PMA number: P950002
Supplement: S013
Product code: MAX
Generic name: Intervertebral fusion device with bone graft, lumbar
Decision date: 2004-01-29
Decision code: APPR
Date received: 2003-12-24
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order 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 DISC CONFIRMED BY HISTORY AND RADIOGRAPHIC STUDIES. THESE PATIENTS SHOULD BE SKELETALLY MATURE AND HAVE HAD SIX MONTHS OF NON-OPERATIVE TREATMENT. VISTA LORDOTIC DEVICES ARE TO BE IMPLANTED VIA AN OPEN ANTERIOR APPROACH.