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Acumed 3006-40040-S

by Acumed LLC

Ref 3006-40040-S

Acumed 3006-40040-S is a device classified as Class IIb in the EU and Class II in the US made by Acumed LLC, registered in EUDAMED on 28 Oct 2026 (Basic UDI-DI B-10806378114748), cleared under FDA 510(k) K123890 on 18 Mar 2013 and listed in FDA GUDID since 23 Sep 2022 (UDI-DI 10806378114748), active as of 7 Nov 2026. 2 FDA recalls are 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

2 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K123890

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-10806378114748 Basic UDI-DI 10806378114748UDI-DIDate28 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10806378114748 UDI-DI Date23 Sep 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK123890 Date18 Mar 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-10806378114748 registered 28 Oct 2026 Active
  • FDA 510(k) K123890 decided 18 Mar 2013 Active
  • FDA GUDID UDI-DI 10806378114748 listed 23 Sep 2022 Listed

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Completed Z-0958-2022 FDA Class II initiated 9 Mar 2022
    • Completed Z-0959-2022 FDA Class II initiated 9 Mar 2022

    Cannulated Screws 4.0mm x 10mm and 4.0mm x 12mm may not have sufficient axial pullout strength for the indicated use. Remote possibility of resulting in a mal or nonunion of the bone fragments, iatrogenic fracture, joint impingement or damage, or soft tissue damage.

Timeline

5 dated events

  1. Cleared FDA 510(k) K123890
  2. Recall initiated FDA recalls Z-0958-2022
  3. Recall initiated FDA recalls Z-0959-2022
  4. Listed FDA GUDID 10806378114748
  5. Registered EUDAMED B-10806378114748

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 bone screw (non-sliding)
Device name
Screw
Model / reference
3006-40040-S
Primary DI / UDI-DI
10806378114748
Basic UDI-DI
B-10806378114748
510(k) Number
FDA product code
HWC
EMDN code
P09120601 Cortical screws
GMDN term
Orthopaedic bone screw (non-sliding)
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3040
EU registration type
Legacy device (under a directive)
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

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 bone screw (non-sliding)

Cleared under the same submission (K123890)

and 8 more cleared under K123890

Similar devices in this category

Other devices filed under CORTICAL SCREWS.

Other devices from Acumed LLC

See all devices from Acumed LLC →

Properties

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