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 | S005 |
Date Received | 03/09/2016 |
Decision Date | 08/23/2016 |
Product Code |
NQO |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the manufacturing sites located at 6688 Dixie Highway, Bridgeport, MI 48722 for the packaging and labeling of the coflex Interlaminar Technology; 11911 Clark Street, Arcadia, CA 91006 for the laser marking, in-process cleaning, and inspection of the coflex Interlaminar Technology; and 1880 Industrial Drive, Libertyville, IL 60048 for the sterilization of the coflex Interlaminar Technology. |
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