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ST4.5L55D

by Newclip Technics

Part of a family of 149 devices: see the family page

Ref ST4.5L55D

ST4.5L55D is a device classified as Class IIb in the EU and Class II in the US made by Newclip Technics, registered in EUDAMED on 15 Jul 2026 (Basic UDI-DI 3700569600258Y), cleared under FDA 510(k) K241539 on 30 Jul 2024 and listed in FDA GUDID since 11 Jun 2026 (UDI-DI 03700569645755), active as of 24 Oct 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K241539

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number3700569600258Y Basic UDI-DI 03700569645755UDI-DIDate15 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03700569645755 UDI-DI Date11 Jun 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK241539 Date30 Jul 2024IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 3700569600258Y registered 15 Jul 2026 Active
  • FDA 510(k) K241539 decided 30 Jul 2024 Active
  • FDA GUDID UDI-DI 03700569645755 listed 11 Jun 2026 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K241539
  2. Listed FDA GUDID 03700569645755
  3. Registered EUDAMED 3700569600258Y

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  • Withdrawn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

Generic name
Orthopaedic bone screw (non-sliding)
Device name
Screws associated to the plates Alians Proximal Humerus, Activmotion S and Xpert PFP
Model / Ref / Catalog
ST4.5L55D
Primary DI / UDI-DI
03700569645755
Basic UDI-DI
3700569600258Y
510(k) Number
FDA product code
HWC
EMDN code
P09120602 Cancellous screws
GMDN term
Orthopaedic bone screw (non-sliding)
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3040
EU registration type
Standard device
EU market of registration
France
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

Cleared under the same submission (K241539)

and 8 more cleared under K241539

Similar devices in this category

Other devices filed under CANCELLOUS SCREWS.

Other devices from Newclip Technics

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  • QBT2.8L20-St

    Class II

  • QBT2.8L22-St

    Class II

See all devices from Newclip Technics →

Properties

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