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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
510(k) Number K252625
Device Name The Response Ortho Smart Fixator - Hexapod System
Applicant
Response Ortho Solutions, LLC
3760 Gorham Way
Boca Raton,  FL  33487
Applicant Contact Isin Sehmuz
Correspondent
Regulatory Insight, Inc.
33 Golden Eagle Lane
Littleton,  CO  80127
Correspondent Contact Kevin Walls
Regulation Number888.3030
Classification Product Code
KTT  
Date Received08/19/2025
Decision Date 11/20/2025
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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