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57930426

by implantcast GmbH

Ref 57930426Model CANCSCR4

57930426 is a device classified as Class IIb in the EU and Class II in the US made by implantcast GmbH, registered in EUDAMED on 18 Sep 2026 (Basic UDI-DI 4048844CANCSCR4V4), cleared under FDA 510(k) K241944 on 10 Mar 2025 and listed in FDA GUDID since 26 Mar 2025 (UDI-DI 04048844648336), active as of 22 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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K241944

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4048844CANCSCR4V4 Basic UDI-DI 04048844648336UDI-DIDate18 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04048844648336 UDI-DI Date26 Mar 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK241944 Date10 Mar 2025DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 4048844CANCSCR4V4 registered 18 Sep 2026 Active
  • FDA 510(k) K241944 decided 10 Mar 2025 Active
  • FDA GUDID UDI-DI 04048844648336 listed 26 Mar 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K241944
  2. Listed FDA GUDID 04048844648336
  3. Registered EUDAMED 4048844CANCSCR4V4

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  • Withdrawn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)
Model / reference
57930426, CANCSCR4
Primary DI / UDI-DI
04048844648336
Basic UDI-DI
4048844CANCSCR4V4
510(k) Number
FDA product code
KWT, HSD, PHX
EMDN code
P09120602 Cancellous screws
GMDN term
Orthopaedic bone screw (non-sliding)
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3650, 888.3690, 888.3660
EU registration type
Standard device
EU market of registration
Germany
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

Category: Orthopaedic bone screw (non-sliding)

Cleared under the same submission (K241944)

Similar devices in this category

Other devices filed under CANCELLOUS SCREWS.

Other devices from implantcast GmbH

See all devices from implantcast GmbH →

Properties

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