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5.0mm Locking screw, Self-tapping 040090046

by Double Medical Technology Inc.

Ref 040090046

5.0mm Locking screw, Self-tapping 040090046 is a device classified as Class IIb in the EU and Class II in the US made by Double Medical Technology Inc., registered in EUDAMED on 20 Apr 2023 (Basic UDI-DI 6902139CS01001A9), cleared under FDA 510(k) K130108 on 19 Apr 2013 and listed in FDA GUDID since 1 Sep 2016 (UDI-DI 06942782409739), active as of 7 Nov 2026.

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

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number6902139CS01001A9 Basic UDI-DI 06942782409739UDI-DIDate20 Apr 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number06942782409739 UDI-DI Date1 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK130108 Date19 Apr 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 6902139CS01001A9 registered 20 Apr 2023 Active
  • FDA 510(k) K130108 decided 19 Apr 2013 Active
  • FDA GUDID UDI-DI 06942782409739 listed 1 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K130108
  2. Listed FDA GUDID 06942782409739
  3. Registered EUDAMED 6902139CS01001A9

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  • Withdrawn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
5.0mm Locking screw, Self-tapping
Generic name
Orthopaedic bone screw (non-sliding)
Device name
locking screw
Model / Ref / Catalog
040090046
Primary DI / UDI-DI
06942782409739
Basic UDI-DI
6902139CS01001A9
510(k) Number
FDA product code
HRS, HWC
EMDN code
P09120699 Bone fixation screws, tendon and ligament synthesis screws - other
GMDN term
Orthopaedic bone screw (non-sliding)
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3030, 888.3040
EU registration type
Standard device
EU market of registration
Romania
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Length — 46.0 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Orthopaedic bone screw (non-sliding)

Cleared under the same submission (K130108)

and 8 more cleared under K130108

Similar devices in this category

Other devices filed under BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER.

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, all answered No)