FDA 510(k) Applications for Medical Device Product Code "MRW"
(System, Facet Screw Spinal Device)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K123218 | ALPHATEC SPINE, INC. | ILLICO FS FACET FIXATION SYSTEM | 11/28/2012 |
| K110170 | ALPHATEC SPINE, INC. | RAPTOR FACET FIXATION SYSTEM | 11/28/2011 |
| K092568 | AMENDIA, INC. | SPARTAN S3 FACET SYSTEM | 11/17/2009 |
| K113011 | AMENDIA, INC. | SPARTAN S3 FACET SYSTEM | 12/06/2011 |
| K120340 | APOLLO SPINE, INC. | VENUS FACET SCREW SYSTEM | 10/19/2012 |
| K121850 | CHOICE SPINE, LP | Typhoon(TM) Facet Screw Fixation System | 09/20/2012 |
| K120597 | CUSTOM SPINE, INC. | KOMPREDA | 05/03/2013 |
| K012773 | DEPUY ACROMED | DISCOVERY FACET SCREW FIXATION SYSTEM | 11/16/2001 |
| K101762 | DEPUY SPINE, INC. | VIPER F2 FACET FIXATION SYSTEM | 11/15/2010 |
| K222515 | Dio Medical Corporation | FaSet Fixation System | 10/05/2022 |
| K112097 | EXACTECH, INC. | GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5 | 11/21/2011 |
| K123497 | FACET-LINK, INC. | FACET SCREW SYSTEM | 02/28/2013 |
| K150223 | FACET-LINK, INC. | Facet-Link Stabilization Platform | 04/28/2015 |
| K192744 | Globus Medical Inc. | CORRIDOR Fixation System | 12/16/2019 |
| K083442 | GLOBUS MEDICAL, INC. | CORRIDOR FIXATION SYSTEM | 02/06/2009 |
| K090952 | GLOBUS MEDICAL, INC. | ZYFUSE FACET FIXATION SYSTEM | 07/14/2009 |
| K031657 | HOWMEDICA OSTEONICS CORP. | STRYKER SPINE OASYS BONE SCREW | 08/22/2003 |
| K180729 | Huvexel Co., Ltd | FaSet Fixation System | 06/28/2018 |
| K090767 | INTERVENTIONAL SPINE, INC. | PERPOS FCD-2 SYSTEM (SINGLE PATIENT USE), ANCHOR, STABILIZER | 06/11/2009 |
| K082795 | INTERVENTIONAL SPINE, INC. | SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANT | 12/12/2008 |
| K101364 | LANX, INC. | LANX FACET SCREW SYSTEM | 08/16/2010 |
| K152137 | LDR SPINE USA | FacetBRIDGE System | 01/25/2016 |
| K161798 | LDR SPINE USA, INC. | FacetBRIDGE« System | 08/04/2016 |
| K090865 | LIFE SPINE | LIFE SPINE FACET SCREW SPINAL SYSTEM | 06/26/2009 |
| K192281 | Medos International SARL | AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine System, BOWTI Anterior Buttress Staple Spinal System, DISCOVERY Screw System, EXPEDIUM Anterior Spine System, FRONTIER Anterior Scoliosis System, KANEDA Anterior Scoli | 11/20/2019 |
| K021705 | MEDTRONIC SOFAMOR DANEK, INC. | MODIFICATION TO TOWNLEY TRANSFACEPEDICULAR SCREW FIXATION SYSTEM | 07/24/2002 |
| K013829 | MEDTRONIC SOFAMOR DANEK, INC. | MODIFICATION TO TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM | 12/19/2001 |
| K003928 | MEDTRONIC SOFAMOR DANEK, INC. | TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM | 01/17/2001 |
| K101765 | MEDTRONIC SPINE LLC. | KYPHON ANCHOR FACET SCREW SYSTEM | 10/22/2010 |
| K121551 | NEUROSTRUCTURES, LLC | RESOLUTE FACET SCREW SYSTEM | 10/23/2012 |
| K131417 | NEXXT SPINE LLC | FACET FIXX | 07/12/2013 |
| K101284 | NUVASIVE, INC. | FACET SCREW SYSTEM | 07/15/2010 |
| K001323 | NUVASIVE, INC. | NUVASIVE PERCUTANEOUS TRANSFACET/INTRAPEDICULAR SCREW | 07/25/2000 |
| K994308 | NUVASIVE, INC. | NUVASIVE TOWNLEY FACET SCREW | 04/18/2000 |
| K020411 | NUVASIVE, INC. | NUVASIVE TRIAD FACET SCREW SYSTEM | 03/12/2002 |
| K102438 | OSTEOMED L.P. | PRIMALOK FACET FIXATION SYSTEM | 09/30/2010 |
| K230297 | Providence Medical Technology, Inc | PMT Expandable Cage (PMT EXP) | 08/11/2023 |
| K220951 | Providence Medical Technology, Inc | PMT Facet Fixation System (PMT FFS) | 12/09/2022 |
| K163374 | PROVIDENCE MEDICAL TECHNOLOGY, INC. | ALLYÖ Facet Screws | 02/16/2017 |
| K183589 | Providence Medical Technology, Inc. | PMT Facet Screw | 10/11/2019 |
| K132859 | SEASPINE, INC. | INTEGRA FACET FIXATION SYSTEM | 11/18/2013 |
| K953076 | SOFAMOR DANEK USA,INC. | TOWNLEY FACET/PEDICULAR SCREW PLATING SYSTEM | 02/28/1997 |
| K132126 | SPECTRUM SPINE, LLC | SPECTRUM SPINE FENESTRATED FACET SCREW SYSTEM | 10/28/2013 |
| K130863 | SPINAL USA | FACET SCREW SYSTEM | 08/09/2013 |
| K142980 | SPINE WAVE, INC. | Proficient (TM) Facet Screw Spine System | 01/16/2015 |
| K071420 | SPINEFRONTIER, INC. | CHAMELEON FIXATION SYSTEM | 01/16/2008 |
| K092464 | SPINEOLOGY, INC. | SPINEOLOGY FACET SCREW | 11/09/2009 |
| K211855 | SurGenTec, LLC | Ion Facet Screw System | 02/25/2022 |
| K073515 | TRANS1 INCORPORATED | TRANS1 FACET SCREW | 03/11/2008 |
| K051856 | TRANS1 INCORPORATED | TRANS1 FACET SCREWS | 09/26/2005 |
| K043351 | TRIAGE MEDICAL INC | 4.5MM BONE-LOK FACET SCREW, MODELS TFCD-45-3040S OR N; SFCD-45-3040S OR N | 02/18/2005 |
| K052043 | TRIAGE MEDICAL, INC. | 3.8MM CS FACET COMPRESSION DEVICE | 10/17/2005 |
| K051949 | TRIAGE MEDICAL, INC. | 4.5 MM LS FACET COMPRESSION DEVICE WITH POLYMER WASHER, MODEL LSPW-45-3040 | 08/05/2005 |
| K062391 | TRIAGE MEDICAL, INC. | DISPOSABLE POSTERIOR LUMBAR STABILIZATION PROCEDURE KIT, MODELS 9045-01 AND 9045-02; COMPRESSION TOOL, MODEL 6113-00 | 09/14/2006 |
| K173198 | U&i Corporation | Facet Screw Fixation System | 01/03/2018 |
| K061041 | US SPINE | US SPINE FACET FIXATION SYSTEM | 06/19/2006 |
| K123932 | X-SPINE SYSTEMS, INC | ZYGAFIX SPINAL FACET SCREW SYSTEM | 05/01/2013 |
| K100154 | X-SPINE SYSTEMS, INC. | FIXCET SPINAL FACET SCREW SYSTEM | 05/21/2010 |
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