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Acumed 3053-40038-S

by Acumed LLC

Ref 3053-40038-S

Acumed 3053-40038-S is a device classified as Class IIb in the EU and Class II in the US made by Acumed LLC, registered in EUDAMED on 28 Oct 2026 (Basic UDI-DI B-10806378122569) and listed in FDA GUDID since 28 Oct 2025 (UDI-DI 10806378122569), active as of 7 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10806378122569 Basic UDI-DI 10806378122569UDI-DIDate28 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10806378122569 UDI-DI Date28 Oct 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-10806378122569 registered 28 Oct 2026 Active
  • FDA GUDID UDI-DI 10806378122569 listed 28 Oct 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10806378122569
  2. Registered EUDAMED B-10806378122569

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Acumed
Generic name
Orthopaedic bone screw (non-sliding)
Device name
Screw
Model / reference
3053-40038-S
Primary DI / UDI-DI
10806378122569
Basic UDI-DI
B-10806378122569
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
MRI safety
MR Conditional

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.

Similar devices in this category

Other devices filed under CORTICAL SCREWS.

Other devices from Acumed LLC

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Properties

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