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510(k) Data Aggregation

    K Number
    K162179
    Device Name
    osteo-WEDGE II ® Open Wedge Bone Locking Plate System
    Manufacturer
    GRAHAM MEDICAL TECHNOLOGIES, L.L.C. DBA GRAMEDICA
    Date Cleared
    2017-01-10

    (159 days)

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

    GRAHAM MEDICAL TECHNOLOGIES, L.L.C. DBA GRAMEDICA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The osteo-WEDGE II ® Open Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations.
    Device Description
    The osteo-WEDGE II® Open Wedge Bone Locking Plate System consists of plates and screws and incorporates a screw-to-plate locking mechanism. The plate is attached to a prepared surface of the involved bone(s) of the foot using six (6) screws for fixation. The fully threaded screws are available in 2 diameters, with numerous lengths and previously cleared under K111326.
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    K Number
    K142534
    Device Name
    HyProCure II
    Manufacturer
    Graham Medical Technologies, L.L.C. dba GraMedica
    Date Cleared
    2014-10-03

    (24 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Graham Medical Technologies, L.L.C. dba GraMedica

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HyProCure II (HYP II and HYP IIs) is an implant stabilization device used in the treatment of hyperpronating instability of the hindfoot. The implant is designed to stabilize the talus to prevent excessive anterior, and/or plantarflexion of the talus, while allowing normal talotarsal joint motion.
    Device Description
    The HyProCure II is an implant which stabilizes the talus on the tarsal mechanism. The system consists of an implant designed to be inserted into the sinus tarsi and corresponding instrumentation to facilitate insertion.
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