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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Augmented Reality
510(k) Number K243980
Device Name ARVIS Surgical Navigation System
Applicant
Kico Knee Innovation Company Pty Limited
Unit 1, 25 Frenchs Forest Rd E
Frenchs Forest,  AU 2086
Applicant Contact Ryan Matthew
Correspondent
Stefanie Michele Auf der Mauer Asmuss
22 Monfield
Rochestown,  IE T12C65D
Correspondent Contact Stefanie Auf der Mauer
Regulation Number882.4560
Classification Product Code
SBF  
Date Received12/23/2024
Decision Date 03/21/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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