This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Modify the general inspection level and acceptable quality level (aql) of the absorbable collagen sponge (acs) component of infuse bone graft to align with iso 14971:2012.
| Device | Infuse Bone Graft/medtronic Interbody Fusion Devise |
| 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 | 2018-10-02 |
| Decision Date | 2018-11-09 |
| PMA | P000058 |
| Supplement | S070 |
| Product Code | NEK |
| Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
| Advisory Committee | Orthopedic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place memphis, TN 38132 |
| 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 |