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    GAP Nail 4.8mm (diameter size) of the GAP ENDO-EXO MEDULLARY SYSTEM. Catalog number GAP-N48-16; GAP-N48-18; GAP-N48-26; GAP-N48-28. Product Usage: The GAP Endo-Exo Medullary System is used for the treatment of fractures or correction of deformities in the femur, tibia and humerus of pediatric patients, who have reached skeletal maturity. The GAP Nail is an intramedullary nail. It is the main component of the GAP Endo-Exo Medullary System. The rest of the components of the system are screws, plates and caps that are assembled to the nail during the surgical procedure. The GAP Endo-Exo Medullary System is indicated as a temporary implant to assure alignment, stabilization and fixation of: long bones that have been surgically prepared (osteotomy) for correction of deformities or fractures caused by trauma or disease. The GAP System is used for pediatric patients (child and adolescent) ages 2 to 21. It can be used to correct the following conditions: -Diaphyseal fracture of the femur, tibia and humerus -Fractures of the femoral neck -Subtrochanteric, intertrochanteric and combination fractures -Correction of deformities (OI, Coxa vara, Coxa valga) -Nonunions and malunions

    FDA Enforcement
    Class II ·Terminated·Pega Medical Inc.·April 8, 2015

    CEMAR ELECTRO INC

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    🇨🇦 Canada·1 Importer

    Kube Innovation Inc

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    🇨🇦 Canada·5 Basic UDI-DIs·5 Devices·1 Importer

    Luméd inc.

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    🇨🇦 Canada·1 Importer

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    🇨🇦 Canada·8 Basic UDI-DIs·44 Devices·2 Importers

    Les Equipements Adaptés PHYSIPRO INC

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    🇨🇦 Canada

    Merrithew International Inc

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    🇨🇦 Canada·9 Basic UDI-DIs·46 Devices·4 Importers

    OrthoPediatrics Canada ULC

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    🇨🇦 Canada·143 Basic UDI-DIs·143 Devices·1 Importer

    Emovi inc.

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    🇨🇦 Canada·2 Basic UDI-DIs·2 Devices

    V2 Max Plus™ Reformer (ONYX) Bundle (with reg. Gearbar)

    Device
    EU MDR · Eu Md Class 1 ·Merrithew International Inc·On the market·29 countries

    V2 Max™ Reformer Bundle (ONYX) (with reg. Gearbar)

    Device
    EU MDR · Eu Md Class 1 ·Merrithew International Inc·On the market·29 countries

    V2 Max Plus™ Reformer (ONYX) Bundle with High Precision Gearbar

    Device
    EU MDR · Eu Md Class 1 ·Merrithew International Inc·On the market·29 countries

    Innobyte Bilateral Clinical Package

    Device
    EU MDR · Eu Md Class 1 ·Kube Innovation Inc·On the market

    Innobyte Bilateral Mouthpiece

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    EU MDR · Eu Md Class 1 ·Kube Innovation Inc·On the market

    V2 Max™ Reformer Bundle (ONYX) with High Precision Gearbar

    Device
    EU MDR · Eu Md Class 1 ·Merrithew International Inc·On the market·29 countries

    SHIN ARCH SECTION, SIZE SMALL

    Device
    EU MDR · Eu Md Class 1 ·Turbomed Orthotics inc.·On the market·26 countries

    SHIN ARCH SECTION, SIZE MEDIUM

    Device
    EU MDR · Eu Md Class 1 ·Turbomed Orthotics inc.·On the market·26 countries

    DORSIFLEX SPRING FRONTIER SMALL (MONOCORE)

    Device
    EU MDR · Eu Md Class 1 ·Turbomed Orthotics inc.·On the market·26 countries

    DORSIFLEX SPRING FRONTIER MEDIUM (MONOCORE)

    Device
    EU MDR · Eu Md Class 1 ·Turbomed Orthotics inc.·On the market·26 countries

    CALF SECTION SIZE MED.LARGE (PRESS. SCREW)

    Device
    EU MDR · Eu Md Class 1 ·Turbomed Orthotics inc.·On the market·26 countries