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ORTHOLOC 3Di 58130006

by Wright Medical Technology, Inc.

Ref 58130006Model 08858251006347TP

ORTHOLOC 3Di 58130006 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 24 Sep 2026 (Basic UDI-DI 08858251006347TP) and listed in FDA GUDID since 1 Oct 2015 (UDI-DI 00840420123213), 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 Number08858251006347TP Basic UDI-DI 00840420123213UDI-DIDate24 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00840420123213 UDI-DI Date1 Oct 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251006347TP registered 24 Sep 2026 Active
  • FDA GUDID UDI-DI 00840420123213 listed 1 Oct 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00840420123213
  2. Registered EUDAMED 08858251006347TP

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  • Withdrawn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
Orthopaedic bone screw (non-sliding)
Model / Ref / Catalog
58130006, 08858251006347TP
Primary DI / UDI-DI
00840420123213
Basic UDI-DI
08858251006347TP
FDA product code
HRS
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
EU registration type
Standard device
EU market of registration
Netherlands
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: 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
  • Sutures
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)