|
Device | SECURE -C CERVICAL ARTIFICIAL DISC |
Generic Name | Prosthesis, intervertebral disc |
Applicant | GLOBUS MEDICAL INC. 2560 GENERAL ARMISTEAD AVE. AUDUBON, PA 19403 |
PMA Number | P100003 |
Supplement Number | S005 |
Date Received | 07/05/2013 |
Decision Date | 12/18/2014 |
Product Code |
MJO |
Advisory Committee |
Orthopedic |
Clinical Trials | NCT00882661
|
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR ADDITIONAL DEVICE SIZES. |