BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Geminus Volar Distal Radius Plate System

    K Number: K182492 · Decision Oct 10, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    18
    Review Days
    29

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    Basic Information

    Device Name
    Geminus Volar Distal Radius Plate System
    K Number
    K182492
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Skeletal Dynamics, LLC
    Date Received
    September 11, 2018
    Decision Date
    October 10, 2018
    Product Code
    HRS
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HRS Plate, Fixation, Bone

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    Other Clearances by Skeletal Dynamics, LLC

    K Number Device Name
    K180744 Stablyx CMC Arthroplasty Implant System
    K172688 Align Radial Head System
    K171590 Distal Elbow Plating System
    K153208 Internal Joint Stabilizer - Elbow
    K150675 Dorsal Spanning Plate
    K143624 Headless Compression Screw System
    K140892 DISTAL ELBOW PLATING SYSTEM
    K140372 FRAGMENT PLATE SYSTEM
    K122310 GEMINUS FOSSA SPECIFIC PLATE SYSTEM
    K122737 GEMINUS FOSSA SPECIFIC PLATE SYSTEM
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