BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇳 India

    Humerus & Ulna System

    K Number: K213108 · Decision Nov 4, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    12
    Review Days
    406

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    Basic Information

    Device Name
    Humerus & Ulna System
    K Number
    K213108
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Auxein Medical Private Limited
    Date Received
    September 24, 2021
    Decision Date
    November 4, 2022
    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 Auxein Medical Private Limited

    K Number Device Name
    K221787 Auxein's DHS/DCS Plate System
    K213059 Tibia and Fibula System
    K213110 AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In Anchor
    K213018 Auxilock GFS Mini, GFS II Large, and GFS Ultimate
    K213014 Varixis Elbow System
    K213109 Auxilock Draw Tight Suture-Based Anchor
    K213104 Auxilock Titanium Screw-In Suture Anchor
    K211324 2.4mm Distal Radius System
    K210792 Auxein Nailing System
    K203029 Auxilock Titanium Interference Screw
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