fixLOCK DHS Plate 4.5 mm - 125° - S.S.

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Device Name

Bone Plating System

Model / Reference

fixLOCK Plating System, 866.125.02

Primary DI / UDI-DI

08905892100017

Basic UDI-DI

8905892GPCLP-01aMR

Direct Marketing DI

08905892100017

EMDN Code

P09120501, P09120502, P09120503, P09120504, P09120599

Device Class

Class IIb

EU market of registration

Denmark

EUDAMED SRN

IN-MF-000014414

Authorised representative

CMC Medical Devices & Drugs SL ES-AR-000000293

• Kirschner Wire, Single Ended - S.S.

  Class IIb

  CE/MDD

• GPC 2.4mm Variable Angle Locking Twon Column Volar Distal Radius Plates, 6 head Holes, GPC 2.4mm Variable Angle Locking Two Column Volar Distal Radius Plates, 7 Head Holes, 2.4 mm Variable Angle Locking Two Column Volar Distal Radius Plate-Narrow, 6 Head Holes, Variable Angle Locking Screw 2.4 mm, Stardrive

  Class II

  FDA 510(k) K210198 Active Cleared 7 Jan 2022

• GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System

  Class II

  FDA 510(k) K163096 Active Cleared 31 Mar 2017

• GPC Intraheal Intramedullary Nailing System

  Class II

  FDA 510(k) K203811 Active Cleared 10 Feb 2022

• GPC Intramedullary Nailing Systems

  Class II

  FDA 510(k) K143245 Active Cleared 30 Sep 2015

• Straight Plate with Gap, 1.5/2.0 mm - 2 Holes

  Class IIb

  CE/MDR

See all devices from GPC Medical Limited →