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 | INFUSE BONE GRAFT/LT- CAGE LUMBAR TAPERED FUSION DEVICE |
Generic Name | Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction |
Applicant | Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, TN 38132 |
PMA Number | P000058 |
Supplement Number | S030 |
Date Received | 11/21/2008 |
Decision Date | 01/20/2010 |
Product Code |
NEK |
Advisory Committee |
Orthopedic |
Supplement Type | 135 Review Track For 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | Yes |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR AN ADDITIONAL SUPPLIER OF BOVINE ACHILLES TENDON FOR THE MANUFACTURE OF THE ABSORBABLE COLLAGEN SPONGE (ACS) COMPONENT OF THE INFUSE BONE GRAFT. |
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