FDA Product Code
FDA Product Code MRW — Clearance Directory
- Device Class
- —
- Assigned Panel
- Unknown
510(k) Clearances — 79 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262618 | Arthrex Spine Compression FT Screw | Arthrex, Inc. | 2026-09-24 | Traditional | PDF ↗ |
| K261209 | Ion-L | SurGenTec, LLC | 2026-06-11 | Traditional | PDF ↗ |
| K253676 | CORUS Posterior Cervical Stabilization System 3D (CORUS PCSS 3D) | Providence Medical Technology, Inc. | 2026-05-14 | Traditional | PDF ↗ |
| K253432 | DiversiVy Facet Screw System | Vy Spine, LLC | 2026-03-19 | Traditional | PDF ↗ |
| K251714 | Ion-C | SurGenTec, LLC | 2026-01-16 | Traditional | PDF ↗ |
| K250679 | FFX Facet Fixation System | Sc Medica | 2025-12-04 | Traditional | PDF ↗ |
| K253190 | CORUS-LX Implant | Providence Medical Technology, Inc. | 2025-11-20 | Traditional | PDF ↗ |
| K252153 | FFX Facet Fixation System | Sc Medica | 2025-10-16 | Traditional | PDF ↗ |
| K251885 | CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant | Providence Medical Technology, Inc. | 2025-07-10 | Special | PDF ↗ |
| K250920 | Arthrex Spine Compression FT Screw | Arthrex, Inc. | 2025-05-22 | Traditional | PDF ↗ |
| K242527 | The Karma® Fixation System | Spinal Elements, Inc. | 2025-05-21 | Traditional | PDF ↗ |
| K243865 | AERO MIS Facet Fusion System | Aurora Spine | 2025-03-24 | Traditional | PDF ↗ |
| K243265 | Ion 3D | SurGenTec, LLC | 2024-12-04 | Special | PDF ↗ |
| K242650 | zLOCK Lumbar Facet Fixation System | Zygofix , Ltd. | 2024-09-20 | Special | PDF ↗ |
| K241035 | PMT Posterior Cervical Stabilization System (PCSS) | Providence Medical Technology, Inc. | 2024-06-25 | Traditional | PDF ↗ |
| K241416 | Ion 3D | SurGenTec, LLC | 2024-06-17 | Special | PDF ↗ |
| K232468 | SC Medica FFX | Sc Medica | 2024-05-09 | Traditional | PDF ↗ |
| K240085 | zLOCK Lumbar Facet Fixation System | Zygofix , Ltd. | 2024-04-18 | Traditional | PDF ↗ |
| K240086 | Ion 3D | SurGenTec, LLC | 2024-02-08 | Special | PDF ↗ |
| K230840 | PMT Facet Fixation System, Lumbar (PMT FFS-LX) | Providence Medical Technology, Inc. | 2023-12-19 | Traditional | PDF ↗ |
| K232877 | FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C Stand Alone System | K&J Consulting Corporation | 2023-12-13 | Traditional | PDF ↗ |
| K230297 | PMT Expandable Cage (PMT EXP) | Providence Medical Technology, Inc. | 2023-08-11 | Traditional | PDF ↗ |
| K220951 | PMT Facet Fixation System (PMT FFS) | Providence Medical Technology, Inc. | 2022-12-09 | Traditional | PDF ↗ |
| K222515 | FaSet Fixation System | Dio Medical Corporation | 2022-10-05 | Traditional | PDF ↗ |
| K211855 | Ion Facet Screw System | SurGenTec, LLC | 2022-02-25 | Traditional | PDF ↗ |
| K192744 | CORRIDOR Fixation System | Globus Medical, Inc. | 2019-12-16 | Traditional | PDF ↗ |
| K192281 | 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 Scoliosis System, KANEDA SR Anterior Spinal System, M-2 Anterior Plate System, MOUNTAINEER Laminoplasty System, PROFILE Anterior Thoracolumbar Plate System, UNIVERSITY PLATE Anterior System, VIPER F2 Facet Fixation System | Medos International SARL | 2019-11-20 | Traditional | PDF ↗ |
| K183589 | PMT Facet Screw | Providence Medical Technology, Inc. | 2019-10-11 | Traditional | PDF ↗ |
| K180729 | FaSet Fixation System | Huvexel Co. , Ltd. | 2018-06-28 | Traditional | PDF ↗ |
| K173198 | Facet Screw Fixation System | U&I Corporation | 2018-01-03 | Traditional | PDF ↗ |
| K163374 | ALLY Facet Screws | Providence Medical Technology, Inc. | 2017-02-16 | Traditional | PDF ↗ |
| K161798 | FacetBRIDGE® System | Ldr Spine USA, Inc. | 2016-08-04 | Special | PDF ↗ |
| K152137 | FacetBRIDGE System | Ldr Spine USA | 2016-01-25 | Traditional | PDF ↗ |
| K150223 | Facet-Link Stabilization Platform | Facet-Link, Inc. | 2015-04-28 | Traditional | PDF ↗ |
| K142980 | Proficient (TM) Facet Screw Spine System | Spine Wave, Inc. | 2015-01-16 | Traditional | PDF ↗ |
| K132859 | INTEGRA FACET FIXATION SYSTEM | Seaspine, Inc. | 2013-11-18 | Traditional | PDF ↗ |
| K132126 | SPECTRUM SPINE FENESTRATED FACET SCREW SYSTEM | Spectrum Spine, LLC | 2013-10-28 | Traditional | PDF ↗ |
| K130863 | FACET SCREW SYSTEM | Spinal USA | 2013-08-09 | Traditional | PDF ↗ |
| K131417 | FACET FIXX | Nexxt Spine, LLC | 2013-07-12 | Traditional | PDF ↗ |
| K120597 | KOMPREDA | Custom Spine, Inc. | 2013-05-03 | Traditional | PDF ↗ |
| K123932 | ZYGAFIX SPINAL FACET SCREW SYSTEM | X-Spine Systems, Inc. | 2013-05-01 | Traditional | PDF ↗ |
| K123497 | FACET SCREW SYSTEM | Facet-Link, Inc. | 2013-02-28 | Traditional | PDF ↗ |
| K123218 | ILLICO FS FACET FIXATION SYSTEM | Alphatec Spine, Inc. | 2012-11-28 | Special | PDF ↗ |
| K121551 | RESOLUTE FACET SCREW SYSTEM | Neurostructures, LLC | 2012-10-23 | Traditional | PDF ↗ |
| K120340 | VENUS FACET SCREW SYSTEM | Apollo Spine, Inc. | 2012-10-19 | Traditional | PDF ↗ |
| K121850 | Typhoon(TM) Facet Screw Fixation System | Choicespine, LP | 2012-09-20 | Traditional | PDF ↗ |
| K113011 | SPARTAN S3 FACET SYSTEM | Amendia, Inc. | 2011-12-06 | Special | PDF ↗ |
| K110170 | RAPTOR FACET FIXATION SYSTEM | Alphatec Spine, Inc. | 2011-11-28 | Traditional | PDF ↗ |
| K112097 | GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5 | Exactech, Inc. | 2011-11-21 | Traditional | PDF ↗ |
| K101762 | VIPER F2 FACET FIXATION SYSTEM | Depuy Spine, Inc. | 2010-11-15 | Special | PDF ↗ |
| K101765 | KYPHON ANCHOR FACET SCREW SYSTEM | Medtronic Spine, LLC | 2010-10-22 | Traditional | PDF ↗ |
| K102438 | PRIMALOK FACET FIXATION SYSTEM | Osteomed LP | 2010-09-30 | Traditional | PDF ↗ |
| K101364 | LANX FACET SCREW SYSTEM | Lanx, Inc. | 2010-08-16 | Traditional | PDF ↗ |
| K101284 | FACET SCREW SYSTEM | Nuvasive, Inc. | 2010-07-15 | Traditional | PDF ↗ |
| K100154 | FIXCET SPINAL FACET SCREW SYSTEM | X-Spine Systems, Inc. | 2010-05-21 | Traditional | PDF ↗ |
| K092568 | SPARTAN S3 FACET SYSTEM | Amendia, Inc. | 2009-11-17 | Traditional | PDF ↗ |
| K092464 | SPINEOLOGY FACET SCREW | Spineology, Inc. | 2009-11-09 | Traditional | PDF ↗ |
| K090952 | ZYFUSE FACET FIXATION SYSTEM | Globus Medical, Inc. | 2009-07-14 | Traditional | PDF ↗ |
| K090865 | LIFE SPINE FACET SCREW SPINAL SYSTEM | Life Spine | 2009-06-26 | Traditional | PDF ↗ |
| K090767 | PERPOS FCD-2 SYSTEM (SINGLE PATIENT USE), ANCHOR, STABILIZER | Interventional Spine, Inc. | 2009-06-11 | Special | PDF ↗ |
| K083442 | CORRIDOR FIXATION SYSTEM | Globus Medical, Inc. | 2009-02-06 | Traditional | PDF ↗ |
| K082795 | SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANT | Interventional Spine, Inc. | 2008-12-12 | Traditional | PDF ↗ |
| K073515 | TRANS1 FACET SCREW | Trans1 Incorporated | 2008-03-11 | Traditional | PDF ↗ |
| K071420 | CHAMELEON FIXATION SYSTEM | Spinefrontier, Inc. | 2008-01-16 | Traditional | PDF ↗ |
| K062391 | DISPOSABLE POSTERIOR LUMBAR STABILIZATION PROCEDURE KIT, MODELS 9045-01 AND 9045-02; COMPRESSION TOOL, MODEL 6113-00 | Triage Medical, Inc. | 2006-09-14 | Traditional | PDF ↗ |
| K061041 | US SPINE FACET FIXATION SYSTEM | Us Spine | 2006-06-19 | Traditional | PDF ↗ |
| K052043 | 3.8MM CS FACET COMPRESSION DEVICE | Triage Medical, Inc. | 2005-10-17 | Traditional | PDF ↗ |
| K051856 | TRANS1 FACET SCREWS | Trans1 Incorporated | 2005-09-26 | Traditional | PDF ↗ |
| K051949 | 4.5 MM LS FACET COMPRESSION DEVICE WITH POLYMER WASHER, MODEL LSPW-45-3040 | Triage Medical, Inc. | 2005-08-05 | Special | PDF ↗ |
| K043351 | 4.5MM BONE-LOK FACET SCREW, MODELS TFCD-45-3040S OR N; SFCD-45-3040S OR N | Triage Medical, Inc. | 2005-02-18 | Traditional | PDF ↗ |
| K031657 | STRYKER SPINE OASYS BONE SCREW | Howmedica Osteonics Corp. | 2003-08-22 | Traditional | PDF ↗ |
| K021705 | MODIFICATION TO TOWNLEY TRANSFACEPEDICULAR SCREW FIXATION SYSTEM | Medtronic Sofamor Danek, Inc. | 2002-07-24 | Special | PDF ↗ |
| K020411 | NUVASIVE TRIAD FACET SCREW SYSTEM | Nuvasive, Inc. | 2002-03-12 | Traditional | PDF ↗ |
| K013829 | MODIFICATION TO TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM | Medtronic Sofamor Danek, Inc. | 2001-12-19 | Special | PDF ↗ |
| K012773 | DISCOVERY FACET SCREW FIXATION SYSTEM | Depuyacromed | 2001-11-16 | Traditional | PDF ↗ |
| K003928 | TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM | Medtronic Sofamor Danek, Inc. | 2001-01-17 | Special | PDF ↗ |
| K001323 | NUVASIVE PERCUTANEOUS TRANSFACET/INTRAPEDICULAR SCREW | Nuvasive, Inc. | 2000-07-25 | Traditional | PDF ↗ |
| K994308 | NUVASIVE TOWNLEY FACET SCREW | Nuvasive, Inc. | 2000-04-18 | Traditional | PDF ↗ |
| K953076 | TOWNLEY FACET/PEDICULAR SCREW PLATING SYSTEM | Sofamor Danek USA,Inc. | 1997-02-28 | Traditional | PDF ↗ |
Product code MRW · · Unknown. Data: openFDA.