Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K052498
    Device Name
    FRAGMENT SPECIFIC FIXATOR
    Manufacturer
    DAVID J. SLUTSKY MD
    Date Cleared
    2005-10-17

    (35 days)

    Product Code
    KTT
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    DAVID J. SLUTSKY MD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fragment Specific fixator is intended for use in adult male and females from skeletal maturity to the geriatric population who have sustained an unstable extra-articular distal radius fracture that cannot be managed by casting, or a 3- or 4-part intra-articular fracture provided the medial fragment is large enough for the insertion of 2 separate 2.5mm - 3.0mm threaded cortical pins. The device can be used in a nonjoint bridging configuration which allows for immediate wrist motion during the fracture healing period of 6-8 weeks. It may alternatively be used in a joint bridging manner to provide ligamentotaxis to obtain and maintain the fracture reduction during the healing period.
    Device Description
    The Fragment Specific Fixator is a single use external fixator designed to provide stable fracture fixation in a nonjoint bridging application that does not cross the wrist or in a joint bridging application that obtains and maintains fracture reduction through ligamentotaxis. The lightweight, radiolucent construct attaches to self drilling bone pins to provide secure fracture fixation and to capture fragments.
    Ask a Question

    Page 1 of 1