Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction
Basic Information
- Device Name
- Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction
- Trade Name
- INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE
- PMA Number
- P000058
- Device Class
- FDA Class 3
- Product Code
- NEK
- Generic Name
- Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
- Medical Specialty
- Unknown
- Advisory Committee
- Orthopedic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- July 2, 2002
- Date Received
- December 22, 2000
- Expedited Review
- Y
- Docket Number
- 02M-0310
Advisory Committee 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-CAGE DEVICES ARE TO BE IMPLANTED VIA AN ANTERIOR OPEN OR AN ANTERIOR LAPAROSCOPIC APPROACH. PATIENTS RECEIVING THE INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE SHOULD HAVE HAD AT LEAST SIX MONTHS OF NONOPERATIVE TREATMENT PRIOR TO TREATMENT WITH THE INFUSE BONE GRAFT/LT-CAGE DEVICE.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NEK | Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction | FDA class 3 | Unknown |