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

    COLLAGEN BONE HEALING PROTECTIVE SHEET

    K Number: K052041 · Decision Oct 25, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    47
    Review Days
    89

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    Basic Information

    Device Name
    COLLAGEN BONE HEALING PROTECTIVE SHEET
    K Number
    K052041
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Collagen Matrix, Inc.
    Date Received
    July 28, 2005
    Decision Date
    October 25, 2005
    Product Code
    HRS
    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
    HRS Plate, Fixation, Bone

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