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

    Clavicle Fixation System

    K Number: K254288 · Decision Mar 23, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    20
    Review Days
    82

    Basic Information

    Device Name
    Clavicle Fixation System
    K Number
    K254288
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Skeletal Dynamics, Inc.
    Date Received
    December 31, 2025
    Decision Date
    March 23, 2026
    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, Inc.

    K Number Device Name
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