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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 K252989
Device Name “POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories Set
Applicant
Point Robotics MedTech, Inc.
7f, #219, Sec.3 Beixin Rd., Xindian Dist.
New Taipei City,  TW
Applicant Contact Wayne Kao
Correspondent
Point Robotics MedTech, Inc.
7f, #219, Sec.3 Beixin Rd., Xindian Dist.
New Taipei City,  TW
Correspondent Contact Brian Fang
Regulation Number882.4560
Classification Product Code
OLO  
Date Received09/18/2025
Decision Date 02/20/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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