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ORTHOLOC 3Di 59250025

by Wright Medical Technology, Inc.

Part of a family of 6 devices: see the family page

Ref 59250025Model 08897970040BMA

ORTHOLOC 3Di 59250025 is a Class I device made by Wright Medical Technology, Inc., registered in EUDAMED on 12 Oct 2026 (Basic UDI-DI 08897970040BMA) and listed in FDA GUDID since 17 Sep 2016 (UDI-DI 00889797022514), active as of 25 Oct 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08897970040BMA Basic UDI-DI 00889797022514UDI-DIDate12 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00889797022514 UDI-DI Date17 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08897970040BMA registered 12 Oct 2026 Active
  • FDA GUDID UDI-DI 00889797022514 listed 17 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00889797022514
  2. Registered EUDAMED 08897970040BMA

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  • Withdrawn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
Surgical drill guide, reusable
Device name
Ortholoc 3Di Ankle Fusion Instruments - GUIDING INSTRUMENTATION - Class I - Reusable-Non Sterile
Model / Ref / Catalog
59250025, 08897970040BMA
Primary DI / UDI-DI
00889797022514
Basic UDI-DI
08897970040BMA
Direct marketing DI
00889797022514
FDA product code
FZX
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Surgical drill guide, reusable
Device class
Class I
Regulation number
878.4800
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: Surgical drill guide, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER.

Other devices from Wright Medical Technology, Inc.

See all devices from Wright Medical Technology, Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (18, all answered No)