BEUDAMED
    253 results · 28ms · Sources: EU EUDAMED, US FDA

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    UNITED STEM, PSA TYPE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AUGMENT AND SCREW, PSA TYPE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    U2 Total Knee System, PSA Tibial Insert

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Stem Extension Line (U2 Total Knee System—PSA Type)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    U2 TOTAL KNEE SYSTEM - PSA TYPE, OFFSET STEM ADAPTER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    U2 Total Knee System Tibial Insert, PSA, #1, 21mm Thick Catalogue number 2303-5016 The U2 Total Knee system is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee cannot be satisfactorily balanced and stabilized at the time of surgery.

    FDA Enforcement
    Class II ·Terminated·United Orthopedic Corporation·March 28, 2018

    U2 Total Knee System Tibial Baseplate, PSA, #2

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·United Orthopedic Corporation·1 device

    U2 Total Knee System Tibial Baseplate, PSA, #5

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·United Orthopedic Corporation·1 device

    U2 Total Knee System Tibial Baseplate, PSA, #6

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·United Orthopedic Corporation·1 device

    U2 Total Knee System Tibial Baseplate, PSA, #3

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·United Orthopedic Corporation·1 device

    U2 Total Knee System Tibial Baseplate, PSA, #1

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·United Orthopedic Corporation·1 device

    U2 Total Knee System Tibial Baseplate, PSA, #4

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·United Orthopedic Corporation·1 device

    U2 Total Knee System Femoral Screw, PSA, M5×12mm

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·United Orthopedic Corporation·1 device

    U2 Total Knee System Femoral Screw, PSA, M5×16mm

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·United Orthopedic Corporation·1 device

    U2 Total Knee System Femoral Screw, PSA, M5×14mm

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·United Orthopedic Corporation·1 device

    U2 Total Knee System Femoral Component, PSA, #1, Right

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·United Orthopedic Corporation·1 device

    U2 Total Knee System Femoral Component, PSA, #3, Right

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·United Orthopedic Corporation·1 device

    U2 Total Knee System Femoral Component, PSA, #1, Left

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·United Orthopedic Corporation·1 device

    U2 Total Knee System Femoral Component, PSA, #3, Left

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·United Orthopedic Corporation·1 device

    U2 Total Knee System Femoral Component, PSA, #2, Right

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·United Orthopedic Corporation·1 device