|
Device | LORDOTEC(TM) TAPERED FUSION DEVICE |
Generic Name | Intervertebral fusion device with bone graft, lumbar |
Regulation Number | 888.3080 |
Applicant | SOFAMOR DANEK 1800 Pyramid Place Memphis, TN 38132 |
PMA Number | P970015 |
Supplement Number | S010 |
Date Received | 11/24/1999 |
Decision Date | 09/28/2000 |
Reclassified Date
|
07/12/2007 |
Product Code |
MAX |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A TAPERED VERSION OF THE INTERFIX(TM) THREADED FUSION DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LT-CAGE(TM) TAPERED FUSION DEVICE AND IS INDICATED FOR SPINAL FUSION PROCEDURES IN SKELETALLY MATURE PATIENTS WITH DEGENERATIVE DISC DISEASE (DDD) AT ONE LEVEL FROM 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(TM) IMPLANTS ARE TO BE USED WITH AUTOGENOUS BONE GRAFT AND IMPLANTED VIA A LAPAROSCOPIC OR AN OPEN ANTERIOR APPROACH. PATIENTS RECEIVING THE LT-CAGE(TM) LUMBAR TAPERED FUSION DEVICE SHOULD HAVE HAD AT LEAST SIX MONTHS OF NONOPERATIVE TREATMENT PRIOR TO TREATMENT WITH THE LT-CAGE(TM) |