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    GMK Sphere CR Tibial Inserts

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 1, 2023

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 14, 2021

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 20, 2021

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 3, 2021

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 4/12 MM R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 8, 2024

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·June 4, 2024

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 7, 2021

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 3/11 MM L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 15, 2022

    GMK SPHERE TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 25, 2026

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 1+ R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 22, 2020

    GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 4+ L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 24, 2020

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 4, 2021

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 17, 2022

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 27, 2023

    GMK PRIMARY TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·June 25, 2025

    GMK PRIMARY TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·January 8, 2026

    GMK PRIMARY TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 18, 2025

    GMK PRIMARY TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 30, 2025

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 11, 2023