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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 K220241
Device Name “POINT” Kinguide Robotic-Assisted Surgical System
Applicant
Point Robotics MedTech, Inc.
7f, #219, Sec.3 Beixin Rd., Xindian Dist.
New Taipei City,  TW 231
Applicant Contact Wayne Kao
Correspondent
Point Robotics MedTech, Inc.
7f, #219, Sec.3 Beixin Rd., Xindian Dist.
New Taipei City,  TW 231
Correspondent Contact Wayne Kao
Regulation Number882.4560
Classification Product Code
OLO  
Date Received01/28/2022
Decision Date 08/09/2022
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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