142 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GMK REVISION EXTENSION
FDA 510(k)
FDA Class 2
·Orthopedic
GMK-SPHERE REVISION FIXED TIBIAL TRAY CEMENTED SIZE 2 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·August 21, 2019
GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/10MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 14, 2018
GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/20MM
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code JWH·April 8, 2016
GMK-REVISION FEMUR REVISION PS SIZE 2 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·April 2, 2019
GMK-REVISION FEMUR CEMENTED STD SIZE 5NARROW / RIGHT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·March 7, 2018
GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/10MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 6, 2018
GMK REVISION TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 26, 2025
GMK PRIMARY TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 28, 2024
GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 1/10MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·November 28, 2019
GMK-REVISION 02.07.0310SCF FIXED TIBIAL INSERT SC SIZE 3/10MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·April 10, 2024
GMK-REVISION FIXED TIBIAL INSERT SC SIZE 6/20MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 23, 2023
3005180920-2018-00592
FDA Adverse Event
Injury
·July 31, 2018
GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/12MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·April 11, 2024
GMK REVISION TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·January 15, 2026
GMK REVISION TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·March 17, 2025
GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/17MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 13, 2021
GMK-REVISION FEMUR PS SIZE 4 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·July 19, 2021
GMK-REVISION FEMUR PS SIZE 2 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·February 10, 2021
GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/26MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·July 14, 2023