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Acumed 71-0428

by Acumed LLC

Ref 71-0428

Acumed 71-0428 is a device classified as Class IIa in the EU and Class II in the US made by Acumed LLC, registered in EUDAMED on 27 Oct 2026 (Basic UDI-DI B-10806378088285), cleared under FDA 510(k) K122538 on 19 Nov 2012 and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 10806378088285), active as of 7 Nov 2026. One FDA recall is linked to it.

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-10806378088285 Basic UDI-DI 10806378088285UDI-DIDate27 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10806378088285 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-10806378088285 registered 27 Oct 2026 Active
  • FDA 510(k) K122538 decided 19 Nov 2012 Active
  • FDA GUDID UDI-DI 10806378088285 listed 24 Oct 2015 Listed

Recalls

1 recall · FDA

    • Terminated Z-1199-2017 FDA Class II initiated 19 Jan 2017

    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.

Timeline

4 dated events

  1. Cleared FDA 510(k) K122538
  2. Listed FDA GUDID 10806378088285
  3. Recall initiated FDA recalls Z-1199-2017
  4. Registered EUDAMED B-10806378088285

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  • Withdrawn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
Orthopaedic fixation plate, non-bioabsorbable
Device name
Trial
Model / reference
71-0428
Primary DI / UDI-DI
10806378088285
Basic UDI-DI
B-10806378088285
510(k) Number
FDA product code
HRS
EMDN code
L091099 Osteosynthesis instruments, reusable - other
GMDN term
Orthopaedic fixation plate, non-bioabsorbable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.3030
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 · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II
ImplantableEUDAMED
No
GUDID
Yes

Device class is stated on each registry's own scale: Class IIa 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 fixation plate, non-bioabsorbable

Cleared under the same submission (K122538)

and 8 more cleared under K122538

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
  • Implantable NoEUDAMEDYesGUDID
  • Reusable
  • Prescription use
  • Lot / batch number
Other properties (20, all answered No)