This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
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.
| Device | AFFINITY (TM) CAGE SYSTEM |
| Generic Name | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Medtronic Sofamor Danek USA, Inc. |
| Date Received | 2000-07-11 |
| Decision Date | 2002-06-13 |
| Notice Date | 2003-11-24 |
| PMA | P000028 |
| Supplement | S |
| Product Code | MAX |
| Docket Number | 03M-0532 |
| Advisory Committee | Orthopedic |
| Expedited Review | Yes |
| Combination Product | No |
| Applicant Address | Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place memphis, TN 38132 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P000028 | Original Filing | |
| S008 | 2006-04-20 | Normal 180 Day Track No User Fee |
| S007 | ||
| S006 | 2004-07-30 | 30-day Notice |
| S005 | 2004-05-19 | Special (immediate Track) |
| S004 | 2003-08-27 | Normal 180 Day Track No User Fee |
| S003 | 2002-11-08 | Normal 180 Day Track |
| S002 | 2002-07-15 | Normal 180 Day Track |
| S001 | 2002-07-09 | Real-time Process |
| Device ID | PMA | Supp |
|---|---|---|
| 00721902307867 | P000028 | 000 |
| 00721902307676 | P000028 | 000 |
| 00721902307690 | P000028 | 000 |
| 00721902307706 | P000028 | 000 |
| 00721902307713 | P000028 | 000 |
| 00721902307737 | P000028 | 000 |
| 00721902307775 | P000028 | 000 |
| 00721902307782 | P000028 | 000 |
| 00721902307805 | P000028 | 000 |
| 00721902307829 | P000028 | 000 |
| 00721902307836 | P000028 | 000 |
| 00721902307843 | P000028 | 000 |
| 00721902307850 | P000028 | 000 |
| 00721902307652 | P000028 | 000 |