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Expedium 186154350

by Depuy Spine, Inc.

Ref 186154350Model EXPEDIUM Spine System Hook

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0705034a001615V Basic UDI-DI 10705034108292UDI-DIDate18 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10705034108292 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

1 recall · FDA

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

    Device does not mate as intended.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Expedium Spine System EUDAMED
Expedium GUDID
Generic Name
Bone-screw internal spinal fixation system hook
Device Name
Angled/Narrow/Wide Blade Hooks, Extended Body Hooks, Reduced Distance Hooks, Left/Right Angled Hooks, Left/Right Offset Hooks
Model / Ref / Catalog
186154350, EXPEDIUM Spine System Hook
Primary DI / UDI-DI
10705034108292
Basic UDI-DI
0705034a001615V
510(k) Number
FDA Product Code
MNH, NKB, MNI, KWQ, OSH, KWP
EMDN Code
P09070302 Thoracolumbosacral fixation systems
GMDN Term
Bone-screw internal spinal fixation system hook
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
888.3070, 888.3060, 888.3050
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

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Category: Bone-screw internal spinal fixation system hook

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Properties

  • Single Use
  • Implantable
  • Sutures
  • Prescription Use
  • Lot / Batch Number

Other properties (20)

  • Sterile: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No