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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K180523
Device Name INTAI Surgery Navigation System
Applicant
Intai Technology Corporation
# 9 Jingke Rd., Nantun Dist.
Taichung,  TW 40852
Applicant Contact Shih-Chang Chuang
Correspondent
Intai Technology Corporation
# 9 Jingke Rd., Nantun Dist.
Taichung,  TW 40852
Correspondent Contact Shih-Chang Chuang
Regulation Number882.4560
Classification Product Code
OLO  
Date Received02/27/2018
Decision Date 09/20/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
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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