Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
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 | S008 |
Date Received | 06/26/2017 |
Decision Date | 04/25/2018 |
Product Code |
NQO |
Advisory Committee |
Orthopedic |
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 introducing a set of disposable instruments for the coflex® and for Otto Klumpp to manufacture these disposable instruments at Burgstraße 18, 72336, Balingen-Ostdorf, Germany. |
|
|