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OrthoView

by Meridian Technique Limited

Ref OrthoView

OrthoView is a medical device (EU MDR Class IIa; FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Meridian Technique Limited, registered in EUDAMED on 14 Oct 2026 (Basic UDI-DI 506068B1000QV), cleared under FDA 510(k) K171068 on 18 Oct 2017 (1 earlier submission) and listed in FDA GUDID since 2 Jul 2025 (UDI-DI 05060687387516), active as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K171068

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number506068B1000QV Basic UDI-DI 05060687387516UDI-DIDate14 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05060687387516 UDI-DI Date2 Jul 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK171068 Date18 Oct 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 506068B1000QV registered 14 Oct 2026 Active
  • FDA 510(k) K171068 decided 18 Oct 2017 Active· +1 more in the status table
  • FDA GUDID UDI-DI 05060687387516 listed 2 Jul 2025 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K063327
  2. Cleared FDA 510(k) K171068
  3. Listed FDA GUDID 05060687387516
  4. Registered EUDAMED 506068B1000QV

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
Orthopaedic/craniofacial implantation planning software
Model / Ref / Catalog
OrthoView
Primary DI / UDI-DI
05060687387516
Basic UDI-DI
506068B1000QV
510(k) Number
FDA product code
LLZ
EMDN code
Z119092 Various bioimaging and radiotherapy instruments - medical device software
GMDN term
Orthopaedic/craniofacial implantation planning software
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.2050
Special device type
Software
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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/craniofacial implantation planning software

Cleared under the same submission (K063327)

and 8 more cleared under K063327

Similar devices in this category

Other devices filed under VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - MEDICAL DEVICE SOFTWARE.

Other devices from Meridian Technique Limited

  • OrthoView 7.3.2

    Class II

  • OrthoView 7.1.3

    Class II

  • OrthoView 7.3.4

    Class II

  • OrthoView 7.0.2

    Class II

See all devices from Meridian Technique Limited →

Properties

  • Measuring function
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)