Intervertebral Fusion Device With Bone Graft, Lumbar
Basic Information
- Device Name
- Intervertebral Fusion Device With Bone Graft, Lumbar
- Trade Name
- LT-CAGE TAPERED FUSION DEVICE
- PMA Number
- P970015
- Supplement Number
- S020
- Device Class
- FDA Class 2
- Product Code
- MAX
- Generic Name
- Intervertebral fusion device with bone graft, lumbar
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Advisory Committee
- Orthopedic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- August 12, 2002
- Date Received
- April 4, 2002
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR A REVISED LAPAROSCOPIC SURGICAL TECHNIQUE FOR IMPLANTATION OF THE LT-CAGE. THE DEVICE REMAINS MARKETED UNDER THE TRADE NAME LT-CAGE TAPERED FUSION DEVICE AND IS INDICATED FOR SPINAL FUSION PROCEDURES IN SKELETALLY MATURE PATIENTS WITH DEGENERATIVE DISC DISEASE (DDD) AT ONE LEVEL FORM L2-S1. DDD IS DEFINED AS DISCOGENIC BACK PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY PATIENT HISTORY AND RADIOGRAPHIC STUDIES. THESE DDD PATIENTS MAY ALSO HAVE UP TO GRADE I SPONDYLOLISTHESIS OR RETROLISTHESIS AT THE INVOLVED LEVEL. LT-CAGE IMPLANTS ARE TO BE USED WITH AUTOGENOUS BONE GRAFT AND IMPLANTED VIA A LAPAROSCOPIC OR AN OPEN ANTERIOR APPROACH. PATIENTS RECEIVING THE LT-CAGE LUMBAR TAPERED FUSION DEVICE SHOULD HAVE HAD AT LEAST SIX MONTHS OF NONOPERATIVE TREATMENT PRIOR TREATMENT WITH THE LT-CAGE.
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 |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | FDA class 2 | Orthopedic |