INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE
FDA premarket approval P000058/S004 · decided 2003-12-01
Approval details
- PMA number
- P000058
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- 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.
- Date received
- 2003-07-01
- Decision date
- 2003-12-01
- Days to decision
- 153 days
- Decision code
- APPR
- Product code
- NEK
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- APPROVAL FOR THE INCLUSION OF ADDITIONAL FUSION CAGE COMPONENT DESIGNS FOR USE WITH THE INFUSE BONE GRAFT COMPONENT. THE FOLLOWING PART NUMBERS WERE NOT INCLUDED AS PART OF THIS REQUEST: 890226, 890229, 890243, 890246, 890249, 9012426 AND 9012429; THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE FOLLOWING TRADE NAMES: INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE; INFUSE BONE GRAFT/INTER FIX THREADED FUSION DEVICE; AND INFUSE BONE GRAFT/INTER FIX RP THREADED FUSION DEVICE. FOR PURPOS
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