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Acumed 71-0416

by Acumed LLC

Ref 71-0416

Acumed 71-0416 is a device classified as Class IIa in the EU and Class II and Class I in the US made by Acumed LLC, registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI B-10806378098116) and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 10806378038280), 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-10806378098116 Basic UDI-DI Date29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10806378038280 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-10806378098116 registered 29 Oct 2026 Active
  • FDA GUDID UDI-DI 10806378038280 listed 24 Oct 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10806378038280
  2. Registered EUDAMED B-10806378098116

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  • Withdrawn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
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Orthopaedic fixation plate bending insert, reusable
Device name
Trial
Model / reference
71-0416, 80-2381
Primary DI / UDI-DI
10806378038280, 10806378098116
Basic UDI-DI
B-10806378098116, B-10806378038280
FDA product code
HRS, LXH
EMDN code
L091099 Osteosynthesis instruments, reusable - other
GMDN term
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Orthopaedic fixation plate bending insert, reusable
Device class
Class IIa EUDAMED
Class II GUDID
Class I GUDID
Regulation number
888.3030, 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 II
Class I

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

Related devices

Category: Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

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
  • Premarket exempt NoGUDIDYesGUDID
  • Lot / batch number
Other properties (21, all answered No)