PMA P970015
- Device
- INTER FIX TM THREADED FUSION DEVICE
- Applicant
- Sofamor Danek
- PMA number
- P970015
- Supplement
- S031
- Product code
- MAX
- Decision date
- 2005-07-27
- Classification
- Intervertebral Fusion Device With Bone Graft, Lumbar
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Approval order statement
- APPROVAL FOR THE POST APPROVAL STUDY. THE DEVICE REMAINS 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. INTER FIX IMPLANTS AND INTER FIX RP IMPLANTS ARE TO BE USED WITH AUTOGENOUS BONE GRAFT AND IMPLANTED VIA AN OPEN ANTERIOR APPROACH.
Current openFDA PMA Record#
- Device
- INTER FIX TM THREADED FUSION DEVICE
- Applicant
- Sofamor Danek
- PMA number
- P970015
- Supplement
- S031
- Product code
- MAX
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Decision date
- 2005-07-27
- Decision code
- APPR
- Date received
- 2005-01-28
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Other
- Approval order statement
- APPROVAL FOR THE POST APPROVAL STUDY. THE DEVICE REMAINS 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. INTER FIX IMPLANTS AND INTER FIX RP IMPLANTS ARE TO BE USED WITH AUTOGENOUS BONE GRAFT AND IMPLANTED VIA AN OPEN ANTERIOR APPROACH.