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GMK 3D Metal Tibial Tray

FDA 510(k)
FDA Class 2 ·Orthopedic

GMK SPHERE CEMENTLESS

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

GMK SPHERE TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 21, 2024

GMK SPHERE TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 5, 2025

GMK 3D METAL TIBIAL TRAY

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 6, 2025

GMK SPHERIKA CEMENTLESS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MBH·December 19, 2025

GMK SPHERIKA CEMENTLESS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MBH·December 24, 2025

GMK 3D METAL TIBIAL TRAY

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MBH·January 23, 2026

GMK 3D METAL TIBIAL TRAY

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 11, 2025

GMK SPHERE TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 19, 2024

GMK SPHERIKA CEMENTLESS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MBH·January 24, 2025

GMK 3D METAL TIBIAL TRAY

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 29, 2025

GMK TOTAL KNEE SYSTEM

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

GMK SPHERE TOTAL KNEE SYSTEM

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code JWH·April 15, 2026

GMK 3D METAL TIBIAL TRAY

FDA Adverse Event
Death ·MEDACTA INTERNATIONAL SA·Product code JWH·January 19, 2026

GMK 3D METAL TIBIAL TRAY

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MBH·February 16, 2026

CoRoent

FDA UDI
Nuvasive, Inc.·00887517300591·CoRoent® XLK, 18x18x50mm 10°

CD HORIZON® Spinal System

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074362557·SCREW 7221850 HA COATED CANN 8.5 X 50

Linear ST ™

FDA UDI
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·M365SC2218500·Linear ST, 50cm 8 Contact Lead Kit

PINNACLE

FDA UDI
DEPUY (IRELAND)·10603295520528·PINNACLE DUAL MOBILITY LINER TRIAL 50/43