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

    Osteotomy Wedge System

    K Number: K252254 · Decision Oct 17, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    17
    Applicant Total
    1
    Review Days
    88

    Basic Information

    Device Name
    Osteotomy Wedge System
    K Number
    K252254
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sinaptic Surgical
    Date Received
    July 21, 2025
    Decision Date
    October 17, 2025
    Product Code
    PLF
    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
    PLF Bone Wedge

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