|
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 | S006 |
Date Received | 08/26/2003 |
Decision Date | 09/17/2003 |
Product Code |
NEK |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR A RETRIEVED IMPLANT PROTOCOL USED TO OBTAIN DATA TO COMPLY WITH ONE OF THE CONDITIONS OF APPROVAL. |