PMA P970015S020

Device: LT-CAGE TAPERED FUSION DEVICE
Applicant: Sofamor Danek
PMA number: P970015
Supplement: S020
Product code: MAX
Decision date: 2002-08-12
Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
Generic name: Intervertebral fusion device with bone graft, lumbar
Approval order 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.

Current openFDA PMA Record#

Device: LT-CAGE TAPERED FUSION DEVICE
Applicant: Sofamor Danek
PMA number: P970015
Supplement: S020
Product code: MAX
Generic name: Intervertebral fusion device with bone graft, lumbar
Decision date: 2002-08-12
Decision code: APPR
Date received: 2002-04-04
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order 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.