Skip to content

ST4.5L20D-St

by Newclip Technics

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

Ref ST4.5L20D-ST

ST4.5L20D-St 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 27 Jul 2026 (UDI-DI 03700569683672), 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) K241539

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number03700569683672 UDI-DI Date27 Jul 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number3700569600258Y Basic UDI-DI 03700569683672UDI-DIDate15 Jul 2026RegisteredStatusActive
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 03700569683672 listed 27 Jul 2026 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K241539
  2. Registered EUDAMED 3700569600258Y
  3. Listed FDA GUDID 03700569683672

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  • Withdrawn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
ST4.5L20D-ST
Primary DI / UDI-DI
03700569683672
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

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

  • Alians Forearm HTSIS2-ST

    Class II

  • QBT2.8L18-St

    Class II

  • QBT2.8L20-St

    Class II

  • QBT2.8L22-St

    Class II

See all devices from Newclip Technics →

Properties

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