63 results · 31ms · Sources: EU EUDAMED, US FDA

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GMK Revision & Hinge Extension - TiNbN Coating

FDA 510(k)
FDA Class 2 ·Orthopedic

GMK REVISION TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 26, 2025

GMK-HINGE FIXED TIBIAL INSERT SIZE 5/17MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code KRO·October 18, 2023

GMK HINGE AND REVISION TINBN COATED

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 7, 2025

GMK HINGE AND REVISION TINBN COATED

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

GMK-HINGE FIXED TIBIAL INSERT SIZE 4/12MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code KRO·March 22, 2024

GMK-REVISION TINBN COATED FEMUR REVISION PS SIZE 4 R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·June 21, 2023

GMK HINGE TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code KRO·March 11, 2025

GMK REVISION TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 31, 2025

GMK PRIMARY TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 21, 2025

GMK-HINGE FIXED TIBIAL INSERT SIZE 5/20MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code KRO·December 28, 2022

GMK HINGE TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code KRO·September 23, 2025

GMK REVISION TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 27, 2026

GMK HINGE TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code KRO·June 24, 2025

GMK HINGE TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code KRO·February 27, 2025

GMK-HINGE FIXED TINBN COATED TIBIAL TRAY - 3R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·February 8, 2023

GMK REVISION TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 9, 2026

GMK REVISION TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 15, 2026

GMK REVISION TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 7, 2025

GMK REVISION TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 3, 2025