PMA P970015S022
- Device
- LT-CAGE PEEK LUMBAR TAPERED FUSION DEVICE
- Applicant
- Sofamor Danek
- PMA number
- P970015
- Supplement
- S022
- Product code
- MAX
- Decision date
- 2003-09-10
- Classification
- Intervertebral Fusion Device With Bone Graft, Lumbar
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Approval order statement
- APPROVAL FOR THE LT-CAGE PEEK LUMBER TAPERED FUSION DEVICE, WHICH IS MANUFACTURED FROM POLYETHERETHERKE-TONE, WITH THE TRADE NAME OF PEEK-OPTIMA LT1. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LT-CAGE PEEK LUMBAR TAPERED FUSION DEVICE AND IS INDICATED FOR SPINAL FUSION PROCEDURES IN SKELETALLY MATURE PATIENTS WITH DEGERNERATIVE 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 ALSO HAVE UP TO GRADE I SPONDYLOLISTHESIS OR RETROLISTHESIS AT THE INVOLVED LEVEL. LT-CAGE PEEK IMPLANTS ARE TO BE USED WITH AUTOGENOUS BONE GRAFT AND IMPLANTED VIA A LAPAROSCOPIC OR AN OPEN ANTERIOR APPROACH. PATIENTS RECEIVING THE LT-CAGE PEEK LUMBAR TAPERED FUSION DEVICE SHOULD HAVE AT LEAST SIX MONTHS OF NON-OPERATIVE TREATMENT PRIOR TREATMENT WITH THE LT-CAGE PEEK DEVICE.
Current openFDA PMA Record#
- Device
- LT-CAGE PEEK LUMBAR TAPERED FUSION DEVICE
- Applicant
- Sofamor Danek
- PMA number
- P970015
- Supplement
- S022
- Product code
- MAX
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Decision date
- 2003-09-10
- Decision code
- APPR
- Date received
- 2002-10-30
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE LT-CAGE PEEK LUMBER TAPERED FUSION DEVICE, WHICH IS MANUFACTURED FROM POLYETHERETHERKE-TONE, WITH THE TRADE NAME OF PEEK-OPTIMA LT1. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LT-CAGE PEEK LUMBAR TAPERED FUSION DEVICE AND IS INDICATED FOR SPINAL FUSION PROCEDURES IN SKELETALLY MATURE PATIENTS WITH DEGERNERATIVE 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 ALSO HAVE UP TO GRADE I SPONDYLOLISTHESIS OR RETROLISTHESIS AT THE INVOLVED LEVEL. LT-CAGE PEEK IMPLANTS ARE TO BE USED WITH AUTOGENOUS BONE GRAFT AND IMPLANTED VIA A LAPAROSCOPIC OR AN OPEN ANTERIOR APPROACH. PATIENTS RECEIVING THE LT-CAGE PEEK LUMBAR TAPERED FUSION DEVICE SHOULD HAVE AT LEAST SIX MONTHS OF NON-OPERATIVE TREATMENT PRIOR TREATMENT WITH THE LT-CAGE PEEK DEVICE.