FDA.reportPublic FDA data

OrthoView

Primary DI
B021734WININD0
Brand
OrthoView
Company
MERIDIAN TECHNIQUE LIMITED
Model
7.3.4
Device description
OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded into it. This enables the surgeon to gather measurements and angles of anatomical landmarks, visualize the effect of the surgery by animating regions of the image, size and position templates representing prosthetic or fixation devices and output reports specifying the measurements and device decisions.
Published
2021-10-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063327000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063327000ORTHOVIEWMerdian Technique, Ltd.2006-11-22LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B021734WININD0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic/craniofacial implantation planning softwareA software program intended to add specific computer-assisted display, processing, and/or analysis capabilities to prepare for the implantation of an orthopaedic and/or craniomaxillofacial (CMF) prosthesis. Using digitized x-rays or imported computed tomography (CT) images, it provides implant-site anatomical images, and using computerized files representing implant patterns, provides the surgeon with images that help determine the appropriate size and placement of the implant.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
640829818
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060687387516OrthoViewOrthoViewOrthoView2025-07-02
B021751WEBWK0OrthoView7.5.12023-12-11
B021751WINWK0OrthoView7.5.12023-12-11
B021711WEBWK0OrthoView7.1.12017-10-19
B021711WINWK0OrthoView7.1.12017-10-19
B02173MACWK0OrthoView7.32018-09-27
B02173WEBIPX0OrthoView7.32018-10-31
B0217502WEBWK0OrthoView7.5.0.22023-04-05
B02175WINIAR0OrthoView7.52022-11-28
B02175WEBWK0OrthoView7.52022-11-17
B02175WINWK0OrthoView7.52022-11-17
B021747WEBWK0OrthoView7.4.72022-08-02
B021746WEBWK0OrthoView7.4.62022-04-06
B021744WEBWK0OrthoView7.4.42020-12-21
B021743WEBWK0OrthoView7.4.32020-11-16
B021742WEBWK0OrthoView7.4.22020-09-18
B021733WINAN0OrthoView7.3.32020-01-03
B021741WEBWK0OrthoView7.4.12019-12-04
B02174WEBWK0OrthoView7.42019-10-01
B021733WEBWK0OrthoView7.3.32019-06-18

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Primary DI, Brand, Company table
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00860005144082Brain AgeDeephealth, Inc.LLZ2026-06-08
07649997938038Swissmeda Dental Planning SystemSwissmeda AGLLZ2026-06-08
07649997938052Swissmeda Dental Planning SystemSwissmeda AGLLZ2026-06-08
00850025268417Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LLZ2026-06-05
00850631008865Roentgen WorksBrit Systems, LLCLLZ2026-06-05