PMA P980048S003

Device: BAK/C VISTA CERVICAL INTERBODY FUSION DEVICE
Applicant: Sulzer Spine-Tech
PMA number: P980048
Supplement: S003
Product code: MAX
Decision date: 2004-10-06
Classification: Orthopedic
Generic name: Intervertebral fusion device with bone graft, lumbar
Approval order statement: APPROVAL FOR THE BAK/C VISTA DEVICE, A MODIFICATION TO THE ALREADY APPROVED BAK/C DEVICE. THE BAK/C VISTA DIFFERS FROM THE BAK/C DEVICE IN THE FOLLOWING MANNERS: 1) THE BAK/C VISTA HAS TWO LARGE OFFSET SUPERIOR-INFERIOR (SI) HOLES FOR BONE INGROWTH WHEREAS THE BAK/C HAS MANY SMALL HOLES AT VARIOUS CIRCUMFERENTIAL AND LONGITUDINAL LOCATIONS, AND 2) THE BAK/C VISTA IS MADE OF PEEK OPTIMA LT1 AND THE BAK/C IS MADE OF TITANIUM (TI-6A1-4V). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BAK/C VISTA AND IS INDICATED FOR USE IN SKELETALLY MATURE PATIENTS WITH DEGENERATIVE DISC DISEASE DDD) OF THE CERVICAL SPINE WITH ACCOMPANYING RADICULAR SYMPTOMS AT ONE DISC LEVEL. DDD IS DEFINED AS DISCOGENIC PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY HISTORY AND RADIOGRAPHIC STUDIES. BAK/C IMPLANTS ARE USED TO FACILITATE FUSION IN THE CERVICAL SPINE AND ARE PLACED VIA AN ANTERIOR APPROACH AT THE C-3 TO C-7 DISC LEVELS USING AUTOGRAFT BONE.

Current openFDA PMA Record#

Device: BAK/C VISTA CERVICAL INTERBODY FUSION DEVICE
Applicant: Sulzer Spine-Tech
PMA number: P980048
Supplement: S003
Product code: MAX
Generic name: Intervertebral fusion device with bone graft, lumbar
Decision date: 2004-10-06
Decision code: APPR
Date received: 2004-04-12
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE BAK/C VISTA DEVICE, A MODIFICATION TO THE ALREADY APPROVED BAK/C DEVICE. THE BAK/C VISTA DIFFERS FROM THE BAK/C DEVICE IN THE FOLLOWING MANNERS: 1) THE BAK/C VISTA HAS TWO LARGE OFFSET SUPERIOR-INFERIOR (SI) HOLES FOR BONE INGROWTH WHEREAS THE BAK/C HAS MANY SMALL HOLES AT VARIOUS CIRCUMFERENTIAL AND LONGITUDINAL LOCATIONS, AND 2) THE BAK/C VISTA IS MADE OF PEEK OPTIMA LT1 AND THE BAK/C IS MADE OF TITANIUM (TI-6A1-4V). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BAK/C VISTA AND IS INDICATED FOR USE IN SKELETALLY MATURE PATIENTS WITH DEGENERATIVE DISC DISEASE DDD) OF THE CERVICAL SPINE WITH ACCOMPANYING RADICULAR SYMPTOMS AT ONE DISC LEVEL. DDD IS DEFINED AS DISCOGENIC PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY HISTORY AND RADIOGRAPHIC STUDIES. BAK/C IMPLANTS ARE USED TO FACILITATE FUSION IN THE CERVICAL SPINE AND ARE PLACED VIA AN ANTERIOR APPROACH AT THE C-3 TO C-7 DISC LEVELS USING AUTOGRAFT BONE.