BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇭 Switzerland

    FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit

    K Number: K253867 · Decision Jan 2, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    4
    Applicant Total
    2
    Review Days
    30

    Basic Information

    Device Name
    FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit
    K Number
    K253867
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ZuriMED Technologies AG
    Date Received
    December 3, 2025
    Decision Date
    January 2, 2026
    Product Code
    OWX
    Advisory Committee
    General, Plastic Surgery
    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
    OWX Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon

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    Other Clearances by ZuriMED Technologies AG

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    K241219 FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN)