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545-20052

by TDM Co., Ltd.

Ref 545-20052, 540-20052

545-20052 is a device classified as Class IIb in the EU and Class II in the US made by TDM Co., Ltd., registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI B-08800043944710), cleared under FDA 510(k) K230071 on 22 Aug 2024 and listed in FDA GUDID since 16 Jan 2025 (UDI-DI 08800043903274), active as of 7 Nov 2026.

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

CE MDD 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) K230071

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/MDD EUDAMED NumberB-08800043944710 Basic UDI-DI Date6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800043903274 UDI-DI Date16 Jan 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK230071 Date22 Aug 2024DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08800043944710 registered 6 Nov 2026 Active
  • FDA 510(k) K230071 decided 22 Aug 2024 Active
  • FDA GUDID UDI-DI 08800043903274 listed 16 Jan 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K230071
  2. Listed FDA GUDID 08800043903274
  3. Registered EUDAMED B-08800043944710

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Non-Sterile Intramedullary Fixation Nail System
Generic name
Orthopaedic bone screw (non-sliding)
Model / Ref / Catalog
545-20052, 540-20052
Description
Nail Locking Screw, Ø4.5mm Large Head 52 mm
Nail Locking Screw, Ø4.0mm Large Head 52 mm
Primary DI / UDI-DI
08800043903274, 08800043944710, 08800043903113
Basic UDI-DI
B-08800043944710, B-08800043903274
510(k) Number
FDA product code
HWC
EMDN code
P09120604 Osteosynthesis nail-screw systems
GMDN term
Orthopaedic bone screw (non-sliding)
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3040
EU registration type
Legacy device (under a directive)
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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 (K230071)

and 8 more cleared under K230071

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS NAIL-SCREW SYSTEMS.

Other devices from TDM Co., Ltd.

See all devices from TDM Co., Ltd. →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)