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

    SF Push-in Anchor

    K Number: K260294 · Decision Mar 27, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    147
    Registration Numbers
    147
    Same Product Code
    219
    Applicant Total
    2
    Review Days
    57

    Basic Information

    Device Name
    SF Push-in Anchor
    K Number
    K260294
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Surgical Fusion Technologies GmbH
    Date Received
    January 29, 2026
    Decision Date
    March 27, 2026
    Product Code
    MAI
    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
    MAI Fastener, Fixation, Biodegradable, Soft Tissue

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    Other Clearances by Surgical Fusion Technologies GmbH

    K Number Device Name
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