PMA P970015S017

Device: INTER FIX RP THREADED FUSION DEVICE-REDUCED PROFILE
Applicant: Sofamor Danek
PMA number: P970015
Supplement: S017
Product code: MAX
Decision date: 2000-12-13
Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
Generic name: Intervertebral fusion device with bone graft, lumbar
Approval order statement: APPROVAL FOR THE INTERFIX(TM) RP THREADED FUSION DEVICE TO BE ALSO KNOWN AS THE INTERFIX(TM) RP THREADED FUSION DEVICE - REDUCED PROFILE. THE DEVICE WILL NOW BE MARKETED UNDER BOTH TRADE NAMES AND WILL REMAIN INDICATED FOR USE WITH AUTOGENOUS BONE BRAFT IN PATIENTS WITH DEGENERATIVE DISC DISEASE (DDD) AT ONE LEVEL FROM L2-S1. THESE DDD PATIENTS MAY ALSO HAVE UP TO GRADE I SPONDYLOLISTHESIS OR RETROLISTHESIS AT THE INVOLVED LEVEL. THE DEVICE IS TO BE IMPLANTED VIA AN OPEN ANTERIOR APPROACH. DDD IS DEFINED AS DISCOGENIC BACK PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY HISTORY AND RADIOGRAPHIC STUDIES. THESE PATIENTS SHOULD BE SKELETALLY MATURE AND HAVE HAD SIX MONTHS OF NON-OPERATIVE TREATMENT.

Current openFDA PMA Record#

Device: INTER FIX RP THREADED FUSION DEVICE-REDUCED PROFILE
Applicant: Sofamor Danek
PMA number: P970015
Supplement: S017
Product code: MAX
Generic name: Intervertebral fusion device with bone graft, lumbar
Decision date: 2000-12-13
Decision code: APPR
Date received: 2000-09-28
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR THE INTERFIX(TM) RP THREADED FUSION DEVICE TO BE ALSO KNOWN AS THE INTERFIX(TM) RP THREADED FUSION DEVICE - REDUCED PROFILE. THE DEVICE WILL NOW BE MARKETED UNDER BOTH TRADE NAMES AND WILL REMAIN INDICATED FOR USE WITH AUTOGENOUS BONE BRAFT IN PATIENTS WITH DEGENERATIVE DISC DISEASE (DDD) AT ONE LEVEL FROM L2-S1. THESE DDD PATIENTS MAY ALSO HAVE UP TO GRADE I SPONDYLOLISTHESIS OR RETROLISTHESIS AT THE INVOLVED LEVEL. THE DEVICE IS TO BE IMPLANTED VIA AN OPEN ANTERIOR APPROACH. DDD IS DEFINED AS DISCOGENIC BACK PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY HISTORY AND RADIOGRAPHIC STUDIES. THESE PATIENTS SHOULD BE SKELETALLY MATURE AND HAVE HAD SIX MONTHS OF NON-OPERATIVE TREATMENT.