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 |
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 | S088 |
Date Received | 05/30/2023 |
Decision Date | 08/25/2023 |
Product Code |
NEK |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for expansion of the approved indications for use of INFUSE® Bone Graft to include implantation with additional interbody fusion devices, a subset of the Anteralign Spinal System with Titan NanoLOCK Surface Technology, specifically the specified sizes of the Anteralign LS and TL systems, utilizing select open surgical procedures in conjunction with supplemental spinal fixation hardware or alone. |
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