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Acumed 3005-40046-S

by Acumed LLC

Acumed 3005-40046-S is a Class II device made by Acumed LLC, cleared under FDA 510(k) K123890 on 18 Mar 2013 and listed in FDA GUDID since 23 Sep 2022 (UDI-DI 10806378115042), active as of 23 Oct 2026. 2 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

510(k) K123890

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10806378115042 UDI-DI Date23 Sep 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK123890 Date18 Mar 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K123890 decided 18 Mar 2013 Active
  • FDA GUDID UDI-DI 10806378115042 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

4 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 10806378115042

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Acumed
Generic name
Orthopaedic bone screw (non-sliding)
Model / reference
3005-40046-S
Primary DI / UDI-DI
10806378115042
510(k) Number
FDA product code
HWC
GMDN term
Orthopaedic bone screw (non-sliding)
Device class
Class II
Regulation number
888.3040
GUDID distribution status
In Commercial Distribution

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 Orthopaedic bone screw (non-sliding).

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 (9, all answered No)