|
Device | coflex® Interlaminar Technology |
Generic Name | Prosthesis, spinous process spacer/plate |
Applicant | Xtant Medical Holdings, Inc. 664 Cruiser Lane Belgrade, MT 59714 |
PMA Number | P110008 |
Supplement Number | S012 |
Date Received | 07/09/2020 |
Decision Date | 08/05/2020 |
Product Code |
NQO |
Advisory Committee |
Orthopedic |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for additional warnings in the labeling. |