Affinity (TM) Cage System
FDA premarket approval P000028 · Intervertebral fusion device with bone graft, lumbar
PMA numberP000028
Approval
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- Received
- July 11, 2000
- Decision date
- June 13, 2002 (APRL)
- Supplements
- 7, latest July 25, 2006
- Product code
- MAX – Intervertebral Fusion Device With Bone Graft, Lumbar
Approval order statement
APPROVAL FOR THE AFFINITY CAGE SYSTEM. THIS DEVICE 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.