|
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 | S003 |
Date Received | 06/21/2013 |
Decision Date | 05/08/2014 |
Product Code |
MJO |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol - OSB |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL. |