This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the infuse bone graft/lt-cage lumbar tapered fusion device. This device is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (ddd) at one level from l4-s1. Ddd is defined as discogenic back pain with degeneration of the disc confirmed by patient history, function deficit and/or neurological deficit and radiographic studies. These ddd patients may also have up to grade i spondylolisthesis at the involved level. Infuse bone graft/lt-cage devices are to be implanted via an anterior open or an anterior laparoscopic approach. Patients receiving the infuse bone graft/lt-cage lumbar tapered fusion device should have had at least six months of nonoperative treatment prior to treatment with the infuse bone graft/lt-cage device.
| Device | INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE |
| Classification Name | Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction |
| Generic Name | Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction |
| Applicant | Medtronic Sofamor Danek USA, Inc. |
| Date Received | 2000-12-22 |
| Decision Date | 2002-07-02 |
| Notice Date | 2002-07-11 |
| PMA | P000058 |
| Supplement | S |
| Product Code | NEK |
| Docket Number | 02M-0310 |
| Advisory Committee | Orthopedic |
| Expedited Review | Yes |
| Combination Product | Yes |
| Applicant Address | Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place memphis, TN 38132 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P000058 | Original Filing | |
| S087 | 2022-07-21 | 30-day Notice |
| S086 | 2022-05-10 | 30-day Notice |
| S085 | 2022-01-20 | 30-day Notice |
| S084 | 2021-03-09 | 30-day Notice |
| S083 | 2021-01-15 | 30-day Notice |
| S082 | 2020-07-30 | 30-day Notice |
| S081 | ||
| S080 | ||
| S079 | ||
| S078 | 2020-06-11 | 30-day Notice |
| S077 | 2019-11-04 | 30-day Notice |
| S076 | 2019-10-31 | 30-day Notice |
| S075 | 2019-09-25 | 30-day Notice |
| S074 | ||
| S073 | ||
| S072 | 2019-06-28 | 30-day Notice |
| S071 | 2018-10-17 | Normal 180 Day Track |
| S070 | 2018-10-02 | 30-day Notice |
| S069 | 2018-08-02 | 30-day Notice |
| S068 | 2017-11-13 | 30-day Notice |
| S067 | 2017-05-23 | 30-day Notice |
| S066 | ||
| S065 | 2017-04-28 | Normal 180 Day Track |
| S064 | 2017-02-03 | 30-day Notice |
| S063 | 2017-01-23 | 30-day Notice |
| S062 | 2016-08-31 | 30-day Notice |
| S061 | 2016-07-11 | 30-day Notice |
| S060 | 2016-06-21 | Normal 180 Day Track |
| S059 | 2015-04-13 | Normal 180 Day Track |
| S058 | 2014-10-29 | Real-time Process |
| S057 | 2014-10-27 | Normal 180 Day Track No User Fee |
| S056 | 2014-01-27 | Normal 180 Day Track |
| S055 | ||
| S054 | 2013-10-25 | Real-time Process |
| S053 | 2013-02-26 | 30-day Notice |
| S052 | 2013-01-14 | 30-day Notice |
| S051 | 2012-12-21 | 30-day Notice |
| S050 | 2012-08-21 | 135 Review Track For 30-day Notice |
| S049 | 2011-12-19 | Normal 180 Day Track |
| S048 | 2011-10-20 | Special (immediate Track) |
| S047 | 2011-10-04 | 135 Review Track For 30-day Notice |
| S046 | 2011-08-26 | Real-time Process |
| S045 | 2011-08-19 | Special (immediate Track) |
| S044 | 2011-06-16 | 135 Review Track For 30-day Notice |
| S043 | 2011-02-15 | 135 Review Track For 30-day Notice |
| S042 | 2011-01-13 | 30-day Notice |
| S041 | 2010-09-30 | 135 Review Track For 30-day Notice |
| S040 | 2010-09-30 | 135 Review Track For 30-day Notice |
| S039 | 2010-09-01 | Normal 180 Day Track No User Fee |
| S038 | 2010-06-03 | 135 Review Track For 30-day Notice |
| S037 | 2010-05-14 | Normal 180 Day Track No User Fee |
| S036 | 2010-02-24 | Special (immediate Track) |
| S035 | ||
| S034 | 2009-09-01 | 135 Review Track For 30-day Notice |
| S033 | 2009-03-25 | 135 Review Track For 30-day Notice |
| S032 | 2009-03-16 | Special (immediate Track) |
| S031 | 2008-12-23 | Real-time Process |
| S030 | 2008-11-21 | 135 Review Track For 30-day Notice |
| S029 | 2008-08-29 | 135 Review Track For 30-day Notice |
| S028 | 2008-01-14 | 135 Review Track For 30-day Notice |
| S027 | 2007-11-16 | Normal 180 Day Track No User Fee |
| S026 | 2007-11-06 | Normal 180 Day Track No User Fee |
| S025 | 2007-07-31 | 135 Review Track For 30-day Notice |
| S024 | ||
| S023 | 2007-04-06 | 135 Review Track For 30-day Notice |
| S022 | 2007-03-05 | Normal 180 Day Track |
| S021 | 2006-12-22 | 135 Review Track For 30-day Notice |
| S020 | 2006-10-27 | Normal 180 Day Track |
| S019 | 2006-10-12 | Special (immediate Track) |
| S018 | ||
| S017 | 2005-02-22 | Real-time Process |
| S016 | 2005-02-04 | 135 Review Track For 30-day Notice |
| S015 | 2004-11-15 | Real-time Process |
| S014 | 2004-09-17 | 135 Review Track For 30-day Notice |
| S013 | ||
| S012 | ||
| S011 | ||
| S010 | 2004-05-20 | Real-time Process |
| S009 | 2004-04-20 | Real-time Process |
| S008 | 2004-03-19 | Special (immediate Track) |
| S007 | 2004-03-04 | Special (immediate Track) |
| S006 | 2003-08-26 | Normal 180 Day Track No User Fee |
| S005 | 2003-08-22 | Normal 180 Day Track No User Fee |
| S004 | 2003-07-01 | Normal 180 Day Track |
| S003 | 2002-12-16 | Normal 180 Day Track |
| S002 | ||
| S001 |