Skip to content

Expedium 186100002

by Depuy Spine, Inc.

Part of a family of 15 devices: see the family page

Ref 186100002Model EXPEDIUM Spine System Locking Component

Expedium 186100002 is a device classified as Class IIb in the EU and Class II in the US made by Depuy Spine, Inc., registered in EUDAMED on 18 Mar 2026 (Basic UDI-DI 0705034a001635Z), cleared under FDA 510(k) K111136 on 14 Jun 2012 (1 earlier submission) and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 10705034103853), active as of 23 Oct 2026. One FDA recall is linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K111136

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0705034a001635Z Basic UDI-DI 10705034103853UDI-DIDate18 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10705034103853 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESU GUDID from GUDID Traditional NumberK111136 Date14 Jun 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0705034a001635Z registered 18 Mar 2026 Active
  • FDA 510(k) K111136 decided 14 Jun 2012 Active· +1 more in the status table
  • FDA GUDID UDI-DI 10705034103853 listed 24 Sep 2015 Listed

Recalls

1 recall · FDA

    • Terminated Z-1674-2015 FDA Class II initiated 21 Apr 2015

    Device does not mate as intended.

Timeline

5 dated events

  1. Cleared FDA 510(k) K081252
  2. Cleared FDA 510(k) K111136
  3. Recall initiated FDA recalls Z-1674-2015
  4. Listed FDA GUDID 10705034103853
  5. Registered EUDAMED 0705034a001635Z

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Expedium Spine System EUDAMED
Expedium GUDID
Generic name
Spinal bone set screw
Device name
Slotted washer, Bolt Polyaxial Washer, Polyaxial Washer, Domed Lock Nut, Swivel, Domed Lock Nut, Domed Nut, Lock Nut, Outerring Nut, etc.
Model / Ref / Catalog
186100002, EXPEDIUM Spine System Locking Component
Primary DI / UDI-DI
10705034103853
Basic UDI-DI
0705034a001635Z
510(k) Number
FDA product code
MNH, KWP, KWQ, OSH, MNI, NKB
EMDN code
P09070302 Thoracolumbosacral fixation systems
GMDN term
Spinal bone set screw
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3070, 888.3050, 888.3060
EU registration type
Standard device
EU market of registration
Belgium
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 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: Spinal bone set screw

Cleared under the same submission (K081252)

and 8 more cleared under K081252

Cleared under the same submission (K111136)

and 8 more cleared under K111136

Similar devices in this category

Other devices filed under THORACOLUMBOSACRAL FIXATION SYSTEMS.

Other devices from Depuy Spine, Inc.

See all devices from Depuy Spine, Inc. →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Sutures
  • Prescription use
  • Lot / batch number
Other properties (20, all answered No)