Search Filters

Search Results

Found 5 results

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.
    Ask a Question
    K Number
    K142478
    Device Name
    opti-Toe
    Manufacturer
    Graham Medical Technologies, L.L.C. (d.b.a.GraMedica)
    Date Cleared
    2015-05-29

    (268 days)

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

    Graham Medical Technologies, L.L.C. (d

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GraMedica opti-Toe Device is indicated for reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. The GraMedica opti-Toe components are to be cemented in place and assembled for reconstruction of the toe. Patients should protect their weight-bearing only until soft tissue healing has occurred.
    Device Description
    The GraMedica opti-Toe is comprised of two mated components (proximal and middle phalangeal) which join together to form a single intramedullary fixation unit. The implants are offered in two sizes, small and large, and the middle phalangeal component is offered with and without a 10 degree angulation.
    Ask a Question
    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.
    Ask a Question
    K Number
    K111326
    Device Name
    OSTEOWEDGE OPENING WEDGE BONE LOCKING SYSTEM
    Manufacturer
    GRAHAM MEDICAL TECHNOLOGIES, L.L.C.
    Date Cleared
    2011-07-06

    (56 days)

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

    GRAHAM MEDICAL TECHNOLOGIES, L.L.C.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OsteoWedge™ Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction 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 OsteoWedge™ 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 plates are available in six (6) wedge sizes. The fully threaded screws are available in 2 diameters, with numerous lengths.
    Ask a Question
    K Number
    K042030
    Device Name
    HYPROCURE SUBTALAR IMPLANT SYSTEM
    Manufacturer
    GRAHAM MEDICAL TECHNOLOGIES, L.L.C.
    Date Cleared
    2004-09-16

    (50 days)

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

    GRAHAM MEDICAL TECHNOLOGIES, L.L.C.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HyProCure Subtalar Implant is indicated for use in the treatment of the hyperpronated foot by stabilization of the subtalar joint. The implant is designed to block anterior, and/or medial, and/or plantarflexion of the talus, while allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.
    Device Description
    Not Found
    Ask a Question

    Page 1 of 1