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Orthex Drill Solid Z402-185-20

by Orthopediatrics Corp.

Part of a family of 67 devices: see the family page

Ref Z402-185-20Model 01-1007-0028

Orthex Drill Solid Z402-185-20 is a device classified as Class IIa in the EU and Class I in the US made by Orthopediatrics Corp., registered in EUDAMED on 29 May 2026 (Basic UDI-DI 08411321CIIADB3F) and listed in FDA GUDID since 2 Mar 2020 (UDI-DI 00841132180730), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08411321CIIADB3F Basic UDI-DI 00841132180730UDI-DIDate29 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841132180730 UDI-DI Date2 Mar 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08411321CIIADB3F registered 29 May 2026 Active
  • FDA GUDID UDI-DI 00841132180730 listed 2 Mar 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00841132180730
  2. Registered EUDAMED 08411321CIIADB3F

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  • Withdrawn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
Orthopediatrics® Orthex External Fixation System Instructions for Use EUDAMED
Orthex Drill Solid GUDID
Generic name
Fluted surgical drill bit, reusable
Device name
Orthopediatrics® Instrumentation
Model / Ref / Catalog
Z402-185-20, 01-1007-0028
Primary DI / UDI-DI
00841132180730
Basic UDI-DI
08411321CIIADB3F
FDA product code
GFG
EMDN code
P091303 Orthopaedic implant drill bits, single-use
GMDN term
Fluted surgical drill bit, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4820
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 IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Fluted surgical drill bit, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC IMPLANT DRILL BITS, SINGLE-USE.

Other devices from Orthopediatrics Corp.

See all devices from Orthopediatrics Corp. →

Properties

  • Sterilise before use
  • Single use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (19, all answered No)