- Device
- DUAL INTERFIX-RP(TM) THREADED FUSION DEVICE
- Applicant
- Sofamor Danek
- PMA number
- P970015
- Supplement
- S019
- Product code
- MAX
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Decision date
- 2001-07-19
- Decision code
- APPR
- Date received
- 2001-04-09
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR USE OF DUAL INTERFIX-RP(TM) THREADED FURSION DEVICES (INSTEAD OF THE ALREADY APPROVED USE OF A SINGLE INTERFIX-RP(TM) THREADED FUSION DEVICE USED IN CONJUNCTION WITH AN INTERFIX(TM) THREADED FUSION DEVICE) THE UNMODIFIED DEVICE WILL CONTINUE TO BE MARKETED UNDER THE TRADE NAME INTERFIX-RP(TM) THREADED FUSION DEVICE AND IS INDICATED FOR SPINAL FUSION PROCEDURES IN SKELETALLY MATURE PATIENTS WTIH 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. INTERFIX-RP(TM) THREADED FUSION DEVICES ARE TO BE USED WITH AUTOGENOUS BONE GRAFT AND IMPLANTED VIA AN OPEN ANTERIOR APPROACH. PATIENTS RECEIVING THE INTERFIX-RP(TM) THREADED FUSION DEVICES SHOULD HAVE HAD AT LEAST SIX MONTHS OF NONOPERATIVE TREATMENT PRIOR TO TREATMENT WITH THE INTERFIX-RP(TM) THREADED FUSION DEVICE.