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Acumed 80-2088

by Acumed LLC

Ref 30-0620

Acumed 80-2088 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-10806378088179) and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 10806378088179), 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-10806378088179 Basic UDI-DI Date29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10806378088179 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-10806378088179 registered 29 Oct 2026 Active
  • FDA GUDID UDI-DI 10806378088179 listed 24 Oct 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10806378088179
  2. Registered EUDAMED B-10806378088179

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  • Withdrawn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
General internal orthopaedic fixation system implantation kit
Orthopaedic bone screw (non-sliding)
Device name
Driver
Screw
Model / reference
30-0620, 80-2088
Primary DI / UDI-DI
10806378088179, 10806378019869
Basic UDI-DI
B-10806378088179, B-10806378019869
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)