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 | S004 |
Date Received | 01/14/2016 |
Decision Date | 02/09/2016 |
Product Code |
NQO |
Advisory Committee |
Orthopedic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Addition of a second supplier for the instruments with the following part numbers: UAT00008, UAT00010, UAT00012, UAT00014, UAT00016, UBT10008, UBT10010, UBT10012, UBT10014, UBT10016, UAT10100, UAT10200, UAT10300, UAT20100, and UAT20110. |
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