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Acumed Fa-0340-S

by Acumed LLC

Ref FA-0340-S

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) K915613

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Overview

ACUMED is a high-quality, non-slip orthopedic bone screw designed for internal fixation of fractures in the extremities. This cannulated screw features a robust design with a unique threaded profile and advanced drive system, providing precise and secure fixation. ACUMED meets the highest standards of quality and safety, making it an ideal choice for clinicians and patients alike.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10806378065866 Basic UDI-DI 10806378065866UDI-DIDate28 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10806378065866 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SN GUDID from GUDID Traditional NumberK915613 Date13 Feb 1992DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-10806378065866 registered 28 Oct 2026 Active
  • FDA 510(k) K915613 decided 13 Feb 1992 Active
  • FDA GUDID UDI-DI 10806378065866 listed 24 Oct 2015 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K915613
  2. Listed FDA GUDID 10806378065866
  3. Registered EUDAMED B-10806378065866

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  • Withdrawn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
FA-0340-S
Primary DI / UDI-DI
10806378065866
Basic UDI-DI
B-10806378065866
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 (K915613)

and 8 more cleared under K915613

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
Other properties (20, all answered No)