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Acumed 7005-13005-S

by Acumed LLC

Ref 7005-13005-S

Acumed 7005-13005-S is an orthopaedic fixation plate (EU MDD Class IIb; FDA Class II; FDA product code HRS, Plate, fixation, bone) made by Acumed LLC, registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI B-10806378088223), cleared under FDA 510(k) K141383 on 13 Jun 2014 and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 10806378088223), 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) K141383

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-10806378088223 Basic UDI-DI 10806378088223UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10806378088223 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK141383 Date13 Jun 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-10806378088223 registered 6 Nov 2026 Active
  • FDA 510(k) K141383 decided 13 Jun 2014 Active
  • FDA GUDID UDI-DI 10806378088223 listed 24 Oct 2015 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K141383
  2. Listed FDA GUDID 10806378088223
  3. Registered EUDAMED B-10806378088223

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  • Withdrawn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
Plate
Model / reference
7005-13005-S
Primary DI / UDI-DI
10806378088223
Basic UDI-DI
B-10806378088223
510(k) Number
FDA product code
HRS
EMDN code
P09120502 Osteosynthesis neutralisation and support plates
GMDN term
Orthopaedic fixation plate, non-bioabsorbable
Device class
Class IIb 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

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II
Sterilise before useEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 10806378088223: EUDAMED states Yes, FDA GUDID states No.

Device class is stated on each registry's own scale: Class IIb 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 (K141383)

and 8 more cleared under K141383

Similar devices in this category

Other devices filed under BONE FIXATION PLATES.

Other devices from Acumed LLC

See all devices from Acumed LLC →

Properties

  • Supplied sterile
  • Sterilise before use YesEUDAMEDNoGUDID
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
Other properties (19, all answered No)