BEUDAMED
    5 results · 24ms · Sources: EU EUDAMED, US FDA

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    TEMA Elbow - Axle Small REF 1590.15.010 TEMA Elbow - Axle Large REF 1590.15.020 TEMA Elbow System is a cemented total elbow prosthesis.

    FDA Enforcement
    Class II ·Ongoing·Limacorporate S.p.A·January 1, 2025

    TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)

    FDA Enforcement
    Class II ·Ongoing·Limacorporate S.p.A·March 22, 2023

    Tema Sinergie S.p.A.

    Importer
    🇮🇹 Italy·7 Manufacturers

    MED 25033

    Certificate
    MDD Annex II (excluding section 4)·Tema Sinergie S.p.a.·KIWA CERMET ITALIA S.P.A.·2 Basic UDI-DIs

    Tema Sinergie S.p.A.

    System producer
    🇮🇹 Italy