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OrthoView 7.1.2

by Meridian Technique Limited 4 variants

OrthoView 7.1.2 is a medical device (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Meridian Technique Limited, cleared under FDA 510(k) K063327 on 22 Nov 2006 and listed in FDA GUDID since 2 Nov 2017 (UDI-DI B021712WINWK70), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K063327

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB021712WINWK70 UDI-DI Date2 Nov 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK063327 Date22 Nov 2006DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K063327 decided 22 Nov 2006 Active
  • FDA GUDID UDI-DI B021712WINWK70 listed 2 Nov 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K063327
  2. Listed FDA GUDID B021712WINWK70

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
OrthoView
Generic name
Orthopaedic/craniofacial implantation planning software
Model / reference
7.1.2
Primary DI / UDI-DI
B021712WINWK70
510(k) Number
FDA product code
LLZ
GMDN term
Orthopaedic/craniofacial implantation planning software
Device class
Class II
Regulation number
892.2050
GUDID distribution status
In Commercial Distribution

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 Orthopaedic/craniofacial implantation planning 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

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)