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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Software For Diagnosis/Treatment
510(k) Number K253764
Device Name ENOS Software Guided External Fixation System
Applicant
Disior, Ltd.
Htc Helsinki, Bldg. Pinta, Tammasaarenkatu 3
Helsinki Uusimaa,  FL  00180
Applicant Contact Aarno Jussila
Correspondent
Paragon 28, Inc.
14445 Grasslands Dr.
Englewood,  CO  80112
Correspondent Contact Edward Wells-Spicer
Regulation Number888.3030
Classification Product Code
OSN  
Date Received11/25/2025
Decision Date 02/26/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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