BEUDAMED
    Product Code: MRW FDA unclassified

    System, Facet Screw Spinal Device

    Unknown

    The Facet Screw Spinal Device System is an orthopedic spinal implant that uses screws anchored in the facet joints of the vertebrae to provide posterior spinal stabilization, used in spinal fusion and stabilization procedures. This device is currently unclassified by the FDA, meaning its formal regulatory classification has not yet been definitively established. The product code is MRW, reviewed by the Orthopedic panel, and carries an implant flag.

    View on FDA
    510(k)s
    78
    FEI Numbers
    100
    Registration Numbers
    100
    Unique Applicants
    46
    Years Active
    29

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    Basic Information

    Product Code
    MRW
    Device Class
    FDA unclassified
    Medical Specialty
    Unknown
    Review Panel
    OR
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Unclassified Reason

    1

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 78 510(k) clearances via K numbers.

    K Number Device Name
    K261209 Ion-L
    K253676 CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D)
    K253432 DiversiVy™ Facet Screw System
    K251714 Ion-C
    K250679 FFX Facet Fixation System
    K253190 CORUS-LX Implant
    K252153 FFX Facet Fixation System
    K251885 CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant
    K250920 Arthrex Spine Compression FT Screw
    K242527 The Karma® Fixation System
    K243865 AERO MIS Facet Fusion System
    K243265 Ion 3D
    K242650 zLOCK Lumbar Facet Fixation System
    K241035 PMT Posterior Cervical Stabilization System (PCSS)
    K241416 Ion 3D
    K232468 SC Medica FFX
    K240085 zLOCK Lumbar Facet Fixation System
    K240086 Ion 3D
    K230840 PMT Facet Fixation System, Lumbar (PMT FFS-LX)
    K232877 FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C™ Stand Alone System
    K230297 PMT Expandable Cage (PMT EXP)
    K220951 PMT Facet Fixation System (PMT FFS)
    K222515 FaSet Fixation System
    K211855 Ion Facet Screw System
    K192744 CORRIDOR Fixation System
    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
    K183589 PMT Facet Screw
    K180729 FaSet Fixation System
    K173198 Facet Screw Fixation System
    K163374 ALLY™ Facet Screws
    K161798 FacetBRIDGE® System
    K152137 FacetBRIDGE System
    K150223 Facet-Link Stabilization Platform
    K142980 Proficient (TM) Facet Screw Spine System
    K132859 INTEGRA FACET FIXATION SYSTEM
    K132126 SPECTRUM SPINE FENESTRATED FACET SCREW SYSTEM
    K130863 FACET SCREW SYSTEM
    K131417 FACET FIXX
    K120597 KOMPREDA
    K123932 ZYGAFIX SPINAL FACET SCREW SYSTEM
    K123497 FACET SCREW SYSTEM
    K123218 ILLICO FS FACET FIXATION SYSTEM
    K121551 RESOLUTE FACET SCREW SYSTEM
    K120340 VENUS FACET SCREW SYSTEM
    K121850 Typhoon(TM) Facet Screw Fixation System
    K113011 SPARTAN S3 FACET SYSTEM
    K110170 RAPTOR FACET FIXATION SYSTEM
    K112097 GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5
    K101762 VIPER F2 FACET FIXATION SYSTEM
    K101765 KYPHON ANCHOR FACET SCREW SYSTEM
    K102438 PRIMALOK FACET FIXATION SYSTEM
    K101364 LANX FACET SCREW SYSTEM
    K101284 FACET SCREW SYSTEM
    K100154 FIXCET SPINAL FACET SCREW SYSTEM
    K092568 SPARTAN S3 FACET SYSTEM
    K092464 SPINEOLOGY FACET SCREW
    K090952 ZYFUSE FACET FIXATION SYSTEM
    K090865 LIFE SPINE FACET SCREW SPINAL SYSTEM
    K090767 PERPOS FCD-2 SYSTEM (SINGLE PATIENT USE), ANCHOR, STABILIZER
    K083442 CORRIDOR FIXATION SYSTEM
    K082795 SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANT
    K073515 TRANS1 FACET SCREW
    K071420 CHAMELEON FIXATION SYSTEM
    K062391 DISPOSABLE POSTERIOR LUMBAR STABILIZATION PROCEDURE KIT, MODELS 9045-01 AND 9045-02; COMPRESSION TOOL, MODEL 6113-00
    K061041 US SPINE FACET FIXATION SYSTEM
    K052043 3.8MM CS FACET COMPRESSION DEVICE
    K051856 TRANS1 FACET SCREWS
    K051949 4.5 MM LS FACET COMPRESSION DEVICE WITH POLYMER WASHER, MODEL LSPW-45-3040
    K043351 4.5MM BONE-LOK FACET SCREW, MODELS TFCD-45-3040S OR N; SFCD-45-3040S OR N
    K031657 STRYKER SPINE OASYS BONE SCREW
    K021705 MODIFICATION TO TOWNLEY TRANSFACEPEDICULAR SCREW FIXATION SYSTEM
    K020411 NUVASIVE TRIAD FACET SCREW SYSTEM
    K013829 MODIFICATION TO TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM
    K012773 DISCOVERY FACET SCREW FIXATION SYSTEM
    K003928 TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM
    K001323 NUVASIVE PERCUTANEOUS TRANSFACET/INTRAPEDICULAR SCREW
    K994308 NUVASIVE TOWNLEY FACET SCREW
    K953076 TOWNLEY FACET/PEDICULAR SCREW PLATING SYSTEM

    FEI Numbers

    This FDA classification entry is associated with 100 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 100 registration numbers. Click on an entry to view related FDA registrations.