Intervertebral Fusion Device With Bone Graft, Lumbar
Basic Information
- Device Name
- Intervertebral Fusion Device With Bone Graft, Lumbar
- Trade Name
- AFFINITY ANTERIOR CERVICAL CAGE SYSTEM
- PMA Number
- P000028
- Supplement Number
- S001
- 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
- August 13, 2002
- Date Received
- July 9, 2002
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR THE FOLLOWING CHANGES TO THE DEVICE: 1) MINOR DESIGN CHANGES TO THE CAGE, MAINLY CONSISTING OF MINOR CHANGES TO THE THREADS; 2) PROVIDE THE DEVICE STERILE; AND 3) CHANGE THE DEVICE NAME TO THE AFFINITY ANTERIOR CERVICAL CAGE SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AFFINITY ANTERIOR CERVICAL CAGE SYSTEM AND IS INDICATED FOR ANTERIOR CERVICAL INTERBODY FUSION PROCEDURES IN SKELETALLY MATURE PATIENTS WITH CERVICAL DISC DISEASE AT ONE LEVEL FROM THE C2-C3 DISC TO THE C7-T1 DISC. CERVICAL DISC DISEASE IS DEFINED AS INTRACTABLE RADICULOPATHY AND/OR MYELOPATHY WITH HERNIATED DISC AND/OR OSTEOPHYTE FORMATION ON POSTERIOR VERTEBRAL ENDPLATES PRODUCING SYMPTOMATIC NERVE ROOT AND/OR SPINAL CORD COMPRESSION CONFIRMED BY RADIOGRAPHIC STUDIES. AFFINITY IMPLANTS ARE TO BE USED WITH AUTOGENOUS BONE GRAFT AND IMPLANTED VIA AN OPEN ANTERIOR APPROACH.
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 |