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

    REGEN COLLAGEN SCAFFOLD (CS)

    K Number: K082079 · Decision Dec 18, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    148

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    Basic Information

    Device Name
    REGEN COLLAGEN SCAFFOLD (CS)
    K Number
    K082079
    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
    Regen Biologics, Inc.
    Date Received
    July 23, 2008
    Decision Date
    December 18, 2008
    Product Code
    OLC
    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
    OLC Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen

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