BEUDAMED
    6 results · 11ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Terminated × Clear all

    SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement.

    FDA Enforcement
    Class II ·Terminated·Limacorporate S.p.A·June 1, 2016

    SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR Shoulder/Spalla Trial Humeral Head diameter .44 mm, REF 9013.22.445; SMR Shoulder/Spalla Trial Humeral Head diameter .46 mm, REF 9013.22.465; for use in shoulder implant surgery.

    FDA Enforcement
    Class II ·Terminated·Limacorporate S.p.A·September 9, 2015

    SMR allen wrench 5 mm, product code 9013.50.210

    FDA Enforcement
    Class II ·Terminated·Limacorporate S.p.A·September 7, 2016

    SMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor, REF 9013.30.021; SMR Shoulder/Spalla Trial Heads ECC .8 mm Adaptor, REF 9013.30.031; for use in shoulder implant surgery.

    FDA Enforcement
    Class II ·Terminated·Limacorporate S.p.A·September 9, 2015

    REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=20mm, STERILE R, 2100099, UDI: (01)08033390018845

    FDA Enforcement
    Class II ·Terminated·Limacorporate S.p.A·October 27, 2021

    REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=25mm, STERILE R, 2100099, UDI: (01)08033390018852

    FDA Enforcement
    Class II ·Terminated·Limacorporate S.p.A·October 27, 2021