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

    ORTHADAPT PR

    K Number: K090288 · Decision May 5, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    139
    Registration Numbers
    139
    Same Product Code
    335
    Applicant Total
    5
    Review Days
    89

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    Basic Information

    Device Name
    ORTHADAPT PR
    K Number
    K090288
    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
    Pegasus Biologics, Inc.
    Date Received
    February 5, 2009
    Decision Date
    May 5, 2009
    Product Code
    FTL
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FTL Mesh, Surgical, Polymeric

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    Other Clearances by Pegasus Biologics, Inc.

    K Number Device Name
    K071425 UNITE BIOMATRIX
    K071065 ORTHADAPT BIOIMPLANT
    K061494 DERMADAPT WOUND DRESSING
    K043388 PEGASUS BIOLOGICS ORTHADAPT SURGICAL MESH