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Acumed 80-4029

by Acumed LLC

Ref 80-4029

Acumed 80-4029 is a device classified as Class IIa in the EU and Class I in the US made by Acumed LLC, registered in EUDAMED on 26 Oct 2026 (Basic UDI-DI B-10806378115967), cleared under FDA 510(k) K233311 on 22 Apr 2024 and listed in FDA GUDID since 5 Jul 2024 (UDI-DI 10806378115967), 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) K233311

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-10806378115967 Basic UDI-DI 10806378115967UDI-DIDate26 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10806378115967 UDI-DI Date5 Jul 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK233311 Date22 Apr 2024DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-10806378115967 registered 26 Oct 2026 Active
  • FDA 510(k) K233311 decided 22 Apr 2024 Active
  • FDA GUDID UDI-DI 10806378115967 listed 5 Jul 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K233311
  2. Listed FDA GUDID 10806378115967
  3. Registered EUDAMED B-10806378115967

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  • Withdrawn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
Acumed
Generic name
Surgical drill guide, reusable
Device name
Trial
Model / reference
80-4029
Primary DI / UDI-DI
10806378115967
Basic UDI-DI
B-10806378115967
510(k) Number
FDA product code
LXH
EMDN code
L091099 Osteosynthesis instruments, reusable - other
GMDN term
Surgical drill guide, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4540
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 IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Surgical drill guide, reusable

Cleared under the same submission (K233311)

and 8 more cleared under K233311

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS INSTRUMENTS, REUSABLE - OTHER.

Other devices from Acumed LLC

See all devices from Acumed LLC →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (22, all answered No)