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. |
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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 | S006 |
Date Received | 09/01/2016 |
Decision Date | 11/30/2016 |
Product Code |
NQO |
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 a change to the coflex® labeling to indicate a 5-year shelf-life for coflex® devices manufactured by the second source manufacturer, Orchid. |
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