INFUSE BONE-GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE
FDA premarket approval P000058/S017 · decided 2005-03-11
Approval details
- PMA number
- P000058
- Supplement
- S017
- Supplement type
- Real-Time Process
- 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
- 2005-02-22
- Decision date
- 2005-03-11
- Days to decision
- 17 days
- Decision code
- APPR
- Product code
- NEK
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- APPROVAL FOR USE OF NEW SHIPPING CONTAINER. THE NEW CONTAINER IS LIGHTER THAN THE CURRENT CONTAINER AND USES POLYSTYRENE INSULATION INSTEAD OF POLYURETHANE.
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