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

    RE-ZORB PLATING SYSTEM

    K Number: K081588 · Decision Sep 3, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    5
    Review Days
    90

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    Basic Information

    Device Name
    RE-ZORB PLATING SYSTEM
    K Number
    K081588
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Acute Innovations, LLC
    Date Received
    June 5, 2008
    Decision Date
    September 3, 2008
    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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    Other Clearances by Acute Innovations, LLC

    K Number Device Name
    K120163 ACUTE INNOVATIONS BIOBRIDGE RESORBABLE PLATING SYSTEM
    K113318 ACUTE INNOVATIONS MODULAR RIBLOC SYSTEM
    K101170 ACUTE INNOVATIONS STERNAL FIXATION SYSTEM
    K061206 ACUTE BONE SCREW