|
Device | coflex Interlaminar Stabilization Device |
Generic Name | Prosthesis, spinous process spacer/plate |
Applicant | Xtant Medical Holdings, Inc. 664 Cruiser Lane Belgrade, MT 59714 |
PMA Number | P110008 |
Supplement Number | S011 |
Date Received | 10/29/2019 |
Decision Date | 04/07/2020 |
Product Code |
NQO |
Advisory Committee |
Orthopedic |
Clinical Trials | NCT02555280
|
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of the revised protocol for the post-approval study (PAS) protocol. |