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ORTHOLOC 3Di 59250010

by Wright Medical Technology, Inc.

Ref 59250010Model 08858251028170UC

ORTHOLOC 3Di 59250010 is a Class I device made by Wright Medical Technology, Inc., registered in EUDAMED on 4 Nov 2026 (Basic UDI-DI 08858251028170UC) and listed in FDA GUDID since 17 Sep 2016 (UDI-DI 00889797022491), active as of 7 Nov 2026.

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

CE MDR

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/MDR EUDAMED Number08858251028170UC Basic UDI-DI 00889797022491UDI-DIDate4 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00889797022491 UDI-DI Date17 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251028170UC registered 4 Nov 2026 Active
  • FDA GUDID UDI-DI 00889797022491 listed 17 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00889797022491
  2. Registered EUDAMED 08858251028170UC

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  • Withdrawn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
ORTHOLOC™ 3Di EUDAMED
ORTHOLOC 3Di GUDID
Generic name
Manual orthopaedic bender, reusable
Device name
Ortholoc 3DI Ankle Fusion Instrumentation - Implant Shaping Instrumentation - Class I - Nonsterile
Model / Ref / Catalog
59250010, 08858251028170UC
Primary DI / UDI-DI
00889797022491
Basic UDI-DI
08858251028170UC
Direct marketing DI
00889797022491
FDA product code
HXW
EMDN code
L091001 Instruments for insertion and extraction of materials for osteosynthesis, reusable
GMDN term
Manual orthopaedic bender, reusable
Device class
Class I
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Manual orthopaedic bender, reusable

Similar devices in this category

Other devices filed under INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE.

Other devices from Wright Medical Technology, Inc.

See all devices from Wright Medical Technology, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)