INFUSE BONE GRAFT/LT-CAGE LUMBER TAPERED FUSION DEVICE
FDA premarket approval P000058/S031 · decided 2009-02-20
Approval details
- PMA number
- P000058
- Supplement
- S031
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INFUSE BONE GRAFT/LT-CAGE LUMBER 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
- 2008-12-23
- Decision date
- 2009-02-20
- Days to decision
- 59 days
- Decision code
- APPR
- Product code
- NEK
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- APPROVAL FOR CHANGES IN THE EXTERIOR CARTONS USED TO SHIP ONE OR MORE UNITS OF INFUSE BONE GRAFT.
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