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

    REGENETEN™ Bioinductive Implant

    K Number: K242631 · Decision Nov 26, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    13
    Applicant Total
    10
    Review Days
    84

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    Basic Information

    Device Name
    REGENETEN™ Bioinductive Implant
    K Number
    K242631
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Smith & Nephew Inc., Endoscopy Div.
    Date Received
    September 3, 2024
    Decision Date
    November 26, 2024
    Product Code
    OWY
    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
    OWY Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon

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