BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    OTS 25-L (100-5)

    K Number: K251310 · Decision Jul 22, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    275
    Registration Numbers
    275
    Same Product Code
    593
    Applicant Total
    3
    Review Days
    85

    Basic Information

    Device Name
    OTS 25-L (100-5)
    K Number
    K251310
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ots Medical , Ltd.
    Date Received
    April 28, 2025
    Decision Date
    July 22, 2025
    Product Code
    MBI
    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
    MBI Fastener, Fixation, Nondegradable, Soft Tissue

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    Other Clearances by Ots Medical , Ltd.

    K Number Device Name
    K241234 OTS 25-L (100-5)
    K233429 OTS 25 (100-1)