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Internal Locking Plate and Screw Fixation System

by Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. 607 variants

Ref 10930305

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K232394↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number697035671JPSD72N6 Basic UDI-DI 06941675457581UDI-DIDate1 Dec 2025RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK232394 Date15 Dec 2023IssuedStatusActive

Certificates

0 certificates · EUDAMED

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

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

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k)

Device Name
2.7/3.5mm LCP Distal Fibula Plate
Model / Reference
10930305
Primary DI / UDI-DI
06941675457581
Basic UDI-DI
697035671JPSD72N6
EMDN Code
P09120503 Osteosynthesis screw-plate systems
Device Class
Class IIb
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000043758
Authorised representative
MedPath GmbH DE-AR-000000087

Other devices from Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.

See all devices from Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. →

Properties

  • Implantable
  • Sutures

Other properties (12)

  • Sterile: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No