Intervertebral Fusion Device With Bone Graft, Lumbar
Basic Information
- Device Name
- Intervertebral Fusion Device With Bone Graft, Lumbar
- Trade Name
- BAK/C VISTA CERVICAL INTERBODY FUSION DEVICE
- PMA Number
- P980048
- Supplement Number
- S003
- Device Class
- FDA Class 2
- Product Code
- MAX
- Generic Name
- Intervertebral fusion device with bone graft, lumbar
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Advisory Committee
- Orthopedic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- October 6, 2004
- Date Received
- April 12, 2004
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | FDA class 2 | Orthopedic |