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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K260077
Device Name OrthoGrid Hip AI® 4.0
Applicant
OrthoGrid Systems, Inc.
7026 S. Commerce Park Dr.
Suite 200
Midvale,  UT  84047
Applicant Contact Shweta Conner
Correspondent
OrthoGrid Systems, Inc.
7026 S. Commerce Park Dr.
Suite 200
Midvale,  UT  84047
Correspondent Contact Shweta Conner
Regulation Number892.2050
Classification Product Code
QIH  
Date Received01/12/2026
Decision Date 05/29/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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