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.
| Device | DUAL INTERFIX-RP(TM) THREADED FUSION DEVICE |
| Classification Name | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Generic Name | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | SOFAMOR DANEK |
| Date Received | 2001-04-09 |
| Decision Date | 2001-07-19 |
| PMA | P970015 |
| Supplement | S019 |
| Product Code | MAX |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SOFAMOR DANEK 1800 Pyramid Place memphis, TN 38132 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P970015 | | Original Filing |
| S031 |
2005-01-28 |
Normal 180 Day Track No User Fee |
| S030 |
2004-11-15 |
Real-time Process |
| S029 |
2004-09-22 |
Real-time Process |
| S028 |
2004-07-01 |
30-day Notice |
| S027 |
2004-03-19 |
Special (immediate Track) |
| S026 |
2004-03-19 |
Special (immediate Track) |
| S025 |
2003-08-25 |
Normal 180 Day Track No User Fee |
| S024 | | |
| S023 | | |
| S022 |
2002-10-30 |
Normal 180 Day Track |
| S021 |
2002-10-25 |
Normal 180 Day Track No User Fee |
| S020 |
2002-04-04 |
Normal 180 Day Track |
| S019 |
2001-04-09 |
Normal 180 Day Track |
| S018 | | |
| S017 |
2000-09-28 |
Normal 180 Day Track |
| S016 | | |
| S015 | | |
| S014 |
2000-05-23 |
Normal 180 Day Track |
| S013 |
2000-02-02 |
Normal 180 Day Track |
| S012 | | |
| S011 |
1999-12-21 |
Normal 180 Day Track |
| S010 |
1999-11-24 |
Normal 180 Day Track |
| S009 |
1999-10-07 |
Normal 180 Day Track |
| S008 |
1999-10-06 |
Normal 180 Day Track |
| S007 | | |
| S006 | | |
| S005 |
1999-08-02 |
Real-time Process |
| S004 | | |
| S003 |
1998-12-04 |
Normal 180 Day Track |
| S002 |
1998-09-09 |
Normal 180 Day Track |
| S001 |
1998-06-15 |
Normal 180 Day Track |
NIH GUDID Devices