|
Device | AFFINITY ANTERIOR CERVICAL CAGE SYSTEM |
Generic Name | Intervertebral fusion device with bone graft, lumbar |
Regulation Number | 888.3080 |
Applicant | Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, TN 38132 |
PMA Number | P000028 |
Supplement Number | S008 |
Date Received | 04/20/2006 |
Decision Date | 07/25/2006 |
Reclassified Date
|
07/12/2007 |
Product Code |
MAX |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES TO THE DEVICE LABELING TO INCORPORATE DATA COLLECTED FROM THE POST MARKET STUDY OF THE DEVICE. |