Atlas FDA

MRW

78 FDA 510(k) clearances · Product code

89 daysmedian time to decision
267 days90th percentile
78clearances measured

FDA profile

Official device name
System, Facet Screw Spinal Device
Device class
Unclassified
Medical specialty
Unknown
Flags
Implant
Adverse events (MAUDE)
2010: 7 · 2011: 62 · 2012: 6
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Ion-L (K261209)SurGenTec, LLC2026-06-11
CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D) (K253676)Providence Medical Technology, Inc.2026-05-14
DiversiVy™ Facet Screw System (K253432)Vy Spine, LLC2026-03-19
Ion-C (K251714)SurGenTec, LLC2026-01-16
FFX Facet Fixation System (K250679)Sc Medica2025-12-04
CORUS-LX Implant (K253190)Providence Medical Technology, Inc.2025-11-20
FFX Facet Fixation System (K252153)Sc Medica2025-10-16
CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant (K251885)Providence Medical Technology, Inc.2025-07-10
Arthrex Spine Compression FT Screw (K250920)Arthrex, Inc.2025-05-22
The Karma® Fixation System (K242527)Spinal Elements, Inc.2025-05-21
AERO MIS Facet Fusion System (K243865)Aurora Spine2025-03-24
Ion 3D (K243265)SurGenTec, LLC2024-12-04
zLOCK Lumbar Facet Fixation System (K242650)Zygofix , Ltd.2024-09-20
PMT Posterior Cervical Stabilization System (PCSS) (K241035)Providence Medical Technology, Inc.2024-06-25
Ion 3D (K241416)SurGenTec, LLC2024-06-17
SC Medica FFX (K232468)Sc Medica2024-05-09
zLOCK Lumbar Facet Fixation System (K240085)Zygofix , Ltd.2024-04-18
Ion 3D (K240086)SurGenTec, LLC2024-02-08
PMT Facet Fixation System, Lumbar (PMT FFS-LX) (K230840)Providence Medical Technology, Inc.2023-12-19
FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C™ Stand Alone System (K232877)K&J Consulting Corporation2023-12-13
PMT Expandable Cage (PMT EXP) (K230297)Providence Medical Technology, Inc.2023-08-11
PMT Facet Fixation System (PMT FFS) (K220951)Providence Medical Technology, Inc.2022-12-09
FaSet Fixation System (K222515)Dio Medical Corporation2022-10-05
Ion Facet Screw System (K211855)SurGenTec, LLC2022-02-25
CORRIDOR Fixation System (K192744)Globus Medical, Inc.2019-12-16
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 (K192281)Medos International SARL2019-11-20
PMT Facet Screw (K183589)Providence Medical Technology, Inc.2019-10-11
FaSet Fixation System (K180729)Huvexel Co. , Ltd.2018-06-28
Facet Screw Fixation System (K173198)U&I Corporation2018-01-03
ALLY™ Facet Screws (K163374)Providence Medical Technology, Inc.2017-02-16
FacetBRIDGE® System (K161798)Ldr Spine USA, Inc.2016-08-04
FacetBRIDGE System (K152137)Ldr Spine USA2016-01-25
Facet-Link Stabilization Platform (K150223)Facet-Link, Inc.2015-04-28
Proficient (TM) Facet Screw Spine System (K142980)Spine Wave, Inc.2015-01-16
INTEGRA FACET FIXATION SYSTEM (K132859)Seaspine, Inc.2013-11-18
SPECTRUM SPINE FENESTRATED FACET SCREW SYSTEM (K132126)Spectrum Spine, LLC2013-10-28
FACET SCREW SYSTEM (K130863)Spinal USA2013-08-09
FACET FIXX (K131417)Nexxt Spine, LLC2013-07-12
KOMPREDA (K120597)Custom Spine, Inc.2013-05-03
ZYGAFIX SPINAL FACET SCREW SYSTEM (K123932)X-Spine Systems, Inc.2013-05-01
FACET SCREW SYSTEM (K123497)Facet-Link, Inc.2013-02-28
ILLICO FS FACET FIXATION SYSTEM (K123218)Alphatec Spine, Inc.2012-11-28
RESOLUTE FACET SCREW SYSTEM (K121551)Neurostructures, LLC2012-10-23
VENUS FACET SCREW SYSTEM (K120340)Apollo Spine, Inc.2012-10-19
Typhoon(TM) Facet Screw Fixation System (K121850)Choicespine, LP2012-09-20
SPARTAN S3 FACET SYSTEM (K113011)Amendia, Inc.2011-12-06
RAPTOR FACET FIXATION SYSTEM (K110170)Alphatec Spine, Inc.2011-11-28
GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5 (K112097)Exactech, Inc.2011-11-21
VIPER F2 FACET FIXATION SYSTEM (K101762)Depuy Spine, Inc.2010-11-15
KYPHON ANCHOR FACET SCREW SYSTEM (K101765)Medtronic Spine, LLC2010-10-22
PRIMALOK FACET FIXATION SYSTEM (K102438)Osteomed LP2010-09-30
LANX FACET SCREW SYSTEM (K101364)Lanx, Inc.2010-08-16
FACET SCREW SYSTEM (K101284)Nuvasive, Inc.2010-07-15
FIXCET SPINAL FACET SCREW SYSTEM (K100154)X-Spine Systems, Inc.2010-05-21
SPARTAN S3 FACET SYSTEM (K092568)Amendia, Inc.2009-11-17
SPINEOLOGY FACET SCREW (K092464)Spineology, Inc.2009-11-09
ZYFUSE FACET FIXATION SYSTEM (K090952)Globus Medical, Inc.2009-07-14
LIFE SPINE FACET SCREW SPINAL SYSTEM (K090865)Life Spine2009-06-26
PERPOS FCD-2 SYSTEM (SINGLE PATIENT USE), ANCHOR, STABILIZER (K090767)Interventional Spine, Inc.2009-06-11
CORRIDOR FIXATION SYSTEM (K083442)Globus Medical, Inc.2009-02-06
SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANT (K082795)Interventional Spine, Inc.2008-12-12
TRANS1 FACET SCREW (K073515)Trans1 Incorporated2008-03-11
CHAMELEON FIXATION SYSTEM (K071420)Spinefrontier, Inc.2008-01-16
DISPOSABLE POSTERIOR LUMBAR STABILIZATION PROCEDURE KIT, MODELS 9045-01 AND 9045-02; COMPRESSION TOOL, MODEL 6113-00 (K062391)Triage Medical, Inc.2006-09-14
US SPINE FACET FIXATION SYSTEM (K061041)Us Spine2006-06-19
3.8MM CS FACET COMPRESSION DEVICE (K052043)Triage Medical, Inc.2005-10-17
TRANS1 FACET SCREWS (K051856)Trans1 Incorporated2005-09-26
4.5 MM LS FACET COMPRESSION DEVICE WITH POLYMER WASHER, MODEL LSPW-45-3040 (K051949)Triage Medical, Inc.2005-08-05
4.5MM BONE-LOK FACET SCREW, MODELS TFCD-45-3040S OR N; SFCD-45-3040S OR N (K043351)Triage Medical, Inc.2005-02-18
STRYKER SPINE OASYS BONE SCREW (K031657)Howmedica Osteonics Corp.2003-08-22
MODIFICATION TO TOWNLEY TRANSFACEPEDICULAR SCREW FIXATION SYSTEM (K021705)Medtronic Sofamor Danek, Inc.2002-07-24
NUVASIVE TRIAD FACET SCREW SYSTEM (K020411)Nuvasive, Inc.2002-03-12
MODIFICATION TO TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM (K013829)Medtronic Sofamor Danek, Inc.2001-12-19
DISCOVERY FACET SCREW FIXATION SYSTEM (K012773)Depuyacromed2001-11-16
TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM (K003928)Medtronic Sofamor Danek, Inc.2001-01-17
NUVASIVE PERCUTANEOUS TRANSFACET/INTRAPEDICULAR SCREW (K001323)Nuvasive, Inc.2000-07-25
NUVASIVE TOWNLEY FACET SCREW (K994308)Nuvasive, Inc.2000-04-18
TOWNLEY FACET/PEDICULAR SCREW PLATING SYSTEM (K953076)Sofamor Danek USA,Inc.1997-02-28

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Every clearance here is in the API, with alerts when new ones post.