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Acumed Lag-4350

by Acumed LLC

Ref LAG-4350

Acumed Lag-4350 is a device classified as Class IIb in the EU and Class II in the US made by Acumed LLC, registered in EUDAMED on 22 Oct 2026 (Basic UDI-DI B-10806378071287), cleared under FDA 510(k) K915613 on 13 Feb 1992 and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 10806378071287), 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) K915613

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-10806378071287 Basic UDI-DI 10806378071287UDI-DIDate22 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10806378071287 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SN GUDID from GUDID Traditional NumberK915613 Date13 Feb 1992DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-10806378071287 registered 22 Oct 2026 Active
  • FDA 510(k) K915613 decided 13 Feb 1992 Active
  • FDA GUDID UDI-DI 10806378071287 listed 24 Oct 2015 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K915613
  2. Listed FDA GUDID 10806378071287
  3. Registered EUDAMED B-10806378071287

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  • Withdrawn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
Acu-Loc EUDAMED
Acumed GUDID
Generic name
Orthopaedic bone screw (non-sliding)
Device name
Screw
Model / reference
LAG-4350
Primary DI / UDI-DI
10806378071287
Basic UDI-DI
B-10806378071287
510(k) Number
FDA product code
HWC
EMDN code
P09120601 Cortical screws
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
Spain
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 (K915613)

and 8 more cleared under K915613

Similar devices in this category

Other devices filed under CORTICAL SCREWS.

Other devices from Acumed LLC

See all devices from Acumed LLC →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
Other properties (20, all answered No)