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Clavicular Locking Plate 020031012

by Double Medical Technology Inc.

Ref 020031012

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K130108

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number6902139CS03006AZ Basic UDI-DI 06942782450243UDI-DIDate31 Oct 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number06942782450243 UDI-DI Date1 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK130108 Date19 Apr 2013DecidedStatusActive

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 7 Nov 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Clavicular Locking Plate
Generic name
Orthopaedic fixation plate, non-bioabsorbable
Device name
Reconstruction Locking Plate, Titanium Alloy
Model / Ref / Catalog
020031012
Primary DI / UDI-DI
06942782450243
Basic UDI-DI
6902139CS03006AZ
510(k) Number
FDA product code
HWC, HRS
EMDN code
P09120501 Osteosynthesis compression plates
GMDN term
Orthopaedic fixation plate, non-bioabsorbable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3040, 888.3030
EU registration type
Standard device
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Length — 142.0 Millimeter
Width — 10.0 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Related devices

Category: Orthopaedic fixation plate, non-bioabsorbable

Cleared under the same submission (K130108)

Show all (12)

Other devices from Double Medical Technology Inc.

See all devices from Double Medical Technology Inc. →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Reprocessed single-use device
  • Sutures
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date

Other properties (17)

  • Supplied sterile: No
  • Reusable: No
  • Contains latex: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No