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

    SpinMedix Absorbable Fibrous Membrane

    K Number: K222220 · Decision Jul 6, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    9
    Applicant Total
    2
    Review Days
    346

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    Basic Information

    Device Name
    SpinMedix Absorbable Fibrous Membrane
    K Number
    K222220
    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
    Celestray Biotech Company, LLC.,
    Date Received
    July 25, 2022
    Decision Date
    July 6, 2023
    Product Code
    OWW
    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
    OWW Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon

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    Other Clearances by Celestray Biotech Company, LLC.,

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