Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K111993
    Device Name
    FRAMEWALKER
    Date Cleared
    2011-10-24

    (103 days)

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

    QUANTUM MEDICAL CONCEPTS, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This device is indicated for use in patients who are undergoing external ring fixation of the Foot and Ankle for the following conditions: For use in the treatment of fracture fixation (open and closed), pseudarthrosis or nonunions of long bones, limb lengthening hy distraction, correction of bony or soft tissue deformities and correction of segmental bony or soft tissue defects.
    Device Description
    Framewalker is a "Single Use" walking aid designed to the foot ring portion of an external ring fixator. The Framewalker is intended for patients who are undergoing procedures requiring ring fixation of the lower extremity. The device is applied to the foot ring portion of a ring fixation frame in order to provide a stable platform below the foot to both protect the bottom of the foot and to allow a patient limited ambulation during treatment as determined by a physician.
    Ask a Question

    Ask a specific question about this device

    K Number
    K101759
    Device Name
    QUANTUM RING FIXATION SYSTEM MODEL ISF
    Date Cleared
    2010-10-22

    (121 days)

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

    QUANTUM MEDICAL CONCEPTS, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1