|
Device | NUVASIVE PCM CERVICAL DISC SYSTEM |
Generic Name | Prosthesis, intervertebral disc |
Applicant | NUVASIVE, INC. 7475 LUSK BLVD SAN DIEGO, CA 92121 |
PMA Number | P100012 |
Supplement Number | S005 |
Date Received | 12/18/2013 |
Decision Date | 03/07/2014 |
Withdrawal Date
|
04/22/2020 |
Product Code |
MJO |
Advisory Committee |
Orthopedic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR DESIGN CHANGES TO THE PCM INSERTER AND REDEFINING AND TIGHTENING IMPLANT TOLERANCES. |