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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 K252755
Device Name POINT Kinguide Agile Robotic Arm Surgical Stereotactic 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 Brian Fang
Regulation Number882.4560
Classification Product Code
OLO  
Date Received08/29/2025
Decision Date 01/23/2026
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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