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540-20038

by TDM Co., Ltd.

Ref 540-20038, 545-20038

540-20038 is a device classified as Class IIb in the EU and Class II and Class I in the US made by TDM Co., Ltd., registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI B-08800043903205), cleared under FDA 510(k) K230071 on 22 Aug 2024 and listed in FDA GUDID since 16 Jan 2025 (UDI-DI 08800043903205), 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-08800043903205 Basic UDI-DI Date6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800043903205 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-08800043903205 registered 6 Nov 2026 Active
  • FDA 510(k) K230071 decided 22 Aug 2024 Active
  • FDA GUDID UDI-DI 08800043903205 listed 16 Jan 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K230071
  2. Listed FDA GUDID 08800043903205
  3. Registered EUDAMED B-08800043903205

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  • Withdrawn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)
External orthopaedic fixation system, reusable
Model / Ref / Catalog
540-20038, 545-20038, PPM-018
Description
Nail Locking Screw, Ø4.0mm Large Head 38 mm
Nail Locking Screw, Ø4.5mm Large Head 38 mm
Container box
Primary DI / UDI-DI
08800043903205, 08800043944642, 08800043903045
Basic UDI-DI
B-08800043903205, B-08800043944642
510(k) Number
FDA product code
HWC, LXH
EMDN code
P09120604 Osteosynthesis nail-screw systems
GMDN term
Orthopaedic bone screw (non-sliding)
External orthopaedic fixation system, reusable
Device class
Class IIb EUDAMED
Class II GUDID
Class I GUDID
Regulation number
888.3040, 888.4540
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
Class I

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II and Class I in the US (FDA GUDID). EU and US classes are different schemes.

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 BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS.

Other devices from TDM Co., Ltd.

See all devices from TDM Co., Ltd. →

Properties

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