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Ortholoc 58934014

by Wright Medical Technology, Inc.

Ref 58934014

Ortholoc 58934014 is a device classified as Class IIb in the EU and Class II in the US made by Wright Medical Technology, Inc., registered in EUDAMED on 5 Nov 2026 (Basic UDI-DI B-00840420114181) and listed in FDA GUDID since 1 Oct 2015 (UDI-DI 00840420114181), active as of 7 Nov 2026.

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

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00840420114181 Basic UDI-DI 00840420114181UDI-DIDate5 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00840420114181 UDI-DI Date1 Oct 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00840420114181 registered 5 Nov 2026 Active
  • FDA GUDID UDI-DI 00840420114181 listed 1 Oct 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00840420114181
  2. Registered EUDAMED B-00840420114181

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Ortholoc
Generic name
Orthopaedic bone screw (non-sliding)
Device name
Cancellous Bone Screw, Full 4.0X14
Model / Ref / Catalog
58934014
Primary DI / UDI-DI
00840420114181
Basic UDI-DI
B-00840420114181
FDA product code
HRS, HWC
EMDN code
P09120503 Osteosynthesis screw-plate systems
GMDN term
Orthopaedic bone screw (non-sliding)
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3030, 888.3040
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Length — 14 Millimeter
Outer Diameter — 4 Millimeter

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)

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS SCREW-PLATE SYSTEMS.

Other devices from Wright Medical Technology, Inc.

See all devices from Wright Medical Technology, Inc. →

Properties

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