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Acumed 80-1875

by Acumed LLC

Ref 30-0358

Acumed 80-1875 is a device classified as Class IIa and Class IIb in the EU and Class I and Class II in the US made by Acumed LLC, registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI B-10806378052019), cleared under FDA 510(k) K122538 on 19 Nov 2012 and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 10806378052019), 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 ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K122538

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-10806378052019 Basic UDI-DI Date29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10806378052019 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK122538 Date19 Nov 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-10806378052019 registered 29 Oct 2026 Active
  • FDA 510(k) K122538 decided 19 Nov 2012 Active
  • FDA GUDID UDI-DI 10806378052019 listed 24 Oct 2015 Listed

Recalls

1 recall · FDA

    • Terminated Z-1199-2017 FDA Class II initiated 19 Jan 2017 on shared 510(k) K122538

    The 6-hole Pubic Symphysis plate (PN 70-0451) is specified to be made of Commercially Pure Titanium (ASTM F67 - CP Grade 4). However, batch 383813 was manufactured out of Titanium Alloy (Ti-6Al- 4V ELI per ASTM F135 Ti alloy) and was distributed.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

4 dated events

  1. Cleared FDA 510(k) K122538
  2. Listed FDA GUDID 10806378052019
  3. Recall initiated FDA recalls Z-1199-2017
  4. Registered EUDAMED B-10806378052019

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  • Withdrawn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
General internal orthopaedic fixation system implantation kit
Orthopaedic bone screw (non-sliding)
Device name
Driver
Screw
Model / reference
30-0358, 80-1875
Primary DI / UDI-DI
10806378052019, 10806378094675
Basic UDI-DI
B-10806378052019, B-10806378094675
510(k) Number
FDA product code
LXH, HWC
EMDN code
P091399, P09120601
GMDN term
General internal orthopaedic fixation system implantation kit
Orthopaedic bone screw (non-sliding)
Device class
Class IIa EUDAMED
Class IIb EUDAMED
Class I GUDID
Class II GUDID
Regulation number
888.4540, 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 IIa
Class IIb
GUDID
Class I
Class II

Device class is stated on each registry's own scale: Class IIa and Class IIb in the EU (EUDAMED), Class I and Class II in the US (FDA GUDID). EU and US classes are different schemes.

Related devices

Category: General internal orthopaedic fixation system implantation kit

Similar devices in this category

Other devices filed under CORTICAL SCREWS.

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Properties

  • Sterilise before use
  • Single use NoGUDIDYesGUDID
  • Implantable NoEUDAMEDGUDIDYesEUDAMEDGUDID
  • Reusable YesEUDAMEDNoEUDAMED
  • Prescription use
  • Premarket exempt YesGUDIDNoGUDID
  • Lot / batch number
Other properties (18, all answered No)