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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K192279
Device Name PhantomMSK Trauma
Applicant
Orthogrid Systems, Inc.
3216 S. Highland, Suite 202
Salt Lake City,  UT  84106
Applicant Contact Sebastian Edin
Correspondent
Orthogrid Systems, Inc.
3216 S. Highland, Suite 202
Salt Lake City,  UT  84106
Correspondent Contact Sebastian Edin
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/22/2019
Decision Date 12/07/2019
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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