|
Device | INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPAERED 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 | S016 |
Date Received | 02/04/2005 |
Decision Date | 04/20/2005 |
Product Code |
NEK |
Advisory Committee |
Orthopedic |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR A NEW REFERENCE STANDARD FOR THE RHBMP-2 COMPONENT. |