INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE
FDA premarket approval P000058 · decided 2002-07-02
Approval details
- PMA number
- P000058
- 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
- 2000-12-22
- Decision date
- 2002-07-02
- Days to decision
- 557 days
- Decision code
- APPR
- Product code
- NEK
- Advisory committee
- Orthopedic
- Expedited review
- Yes
- Location
- Memphis, TN
- Statement
- APPROVAL FOR THE INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE. THIS DEVICE IS INDICATED FOR SPINAL FUSION PROCEDURES IN SKELETALLY MATURE PATIENTS WITH DEGENERATIVE DISC DISEASE (DDD) AT ONE LEVEL FROM L4-S1. DDD IS DEFINED AS DISCOGENIC BACK PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY PATIENT HISTORY, FUNCTION DEFICIT AND/OR NEUROLOGICAL DEFICIT AND RADIOGRAPHIC STUDIES. THESE DDD PATIENTS MAY ALSO HAVE UP TO GRADE I SPONDYLOLISTHESIS AT THE INVOLVED LEVEL. INFUSE BONE GRAFT/LT-CA
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