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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 K230252
Device Name OFIX MIS App
Applicant
Orthofix US LLC
3451 Plano Parkway
Lewisville,  TX  75056
Applicant Contact Shant Aghyarian
Correspondent
Orthofix US LLC
3451 Plano Parkway
Lewisville,  TX  75056
Correspondent Contact Shant Aghyarian
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/30/2023
Decision Date 09/26/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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