Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010342382

FEI Number

3010342382

Entity Name

ORTHOGRID SYSTEMS, INC

City/State/Country

Midvale, UT, US

Establishment Address

7026 S Commerce Park Dr, Midvale, UT 84047, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

OrthoGrid Systems, Inc. (Owner Number: 10044516)

Owner / Operator Contact Address

7026 S Commerce Park Dr, Midvale, UT 84047, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

OrthoGrid Trauma PhantomMSK Hip, OrthoGrid Hip, PhantomMSK Hip Preservation, OrthoGrid Hip Preservation PhantomMSK Hip PhantomMSK Hip Preservation OrthoGrid Hip AI 4 PhantomMSK Hip PhantomMSK Hip Preservation HipGrid NINE D197649

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2021-08-26
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2021-02-19
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2017-12-13
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2026-06-05
HWT	Template	Orthopedic	Class 1	888.4800	2013-06-21

Official Correspondent

Justin Turner

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

OrthoGrid Systems, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K080013	Agfa Healthcare Corporation	REGISTRATION AND FUSION	2008-01-17
K042221	Barco NV Barcoview	CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM	2004-12-30
K092915	Cedara Software Corp.	CEDARA WEBACCESS, MODEL: 2.4	2010-06-23
K961871	Siemens Medical Solutions USA, Inc.	FLOUROSPOT T.O.P.	1996-07-31
K122260	Aycan Digitalsysteme GmbH	AYCAN MOBILE	2012-09-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016	GE Healthcare	2	Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026	CHANGE HEALTHCARE CANADA COMPANY	2	Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012	Philips Healthcare Inc.	2	MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007	AGFA Corp.	2	IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

Similar Registrations

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3017991646	CARDIOWISE, INC.	Fayetteville, AR, US
3007120336	GE Healthcare Magyarorszag Kft.	Budapest, HU
3036758981	TAEYOUNG SOFT	Gwacheon-si Gyeonggi, KR
3010956703	Visual Medica	Ciudad Autonoma Buenos Aires Buenos Aires, Ciudad Autonoma de, AR
3030088963	REBRAIN	PESSAC Gironde, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010342382. Last updated year: 2026. Please use registration number 3010342382 when referencing this establishment in official correspondence.