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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Fixation, Smooth
510(k) Number K250315
Device Name RONAVIS – FX (FX-001)
Applicant
AIRS, Inc.
Robot Innovation Center Kiria 75, Nowon-Ru, Buk-Gu
Rm. 202
Daegu,  KR 41496
Applicant Contact Sanghyun Joung
Correspondent
AIRS, Inc.
Robot Innovation Center Kiria 75, Nowon-Ru, Buk-Gu
Rm. 202
Daegu,  KR 41496
Correspondent Contact Sanghyun Joung
Regulation Number888.3040
Classification Product Code
HTY  
Date Received02/04/2025
Decision Date 08/01/2025
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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