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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 K262506
Device Name Remex Spine Surgery Navigation - Universal Instruments
Applicant
Remex Medical Corp.
4f, #9, Jingke Rd., Nantun District
Taichung,  TW 408209
Applicant Contact Jessie Wang
Correspondent
Remex Medical Corp.
4f, #9, Jingke Rd., Nantun District
Taichung,  TW 408209
Correspondent Contact Jessie Wang
Regulation Number882.4560
Classification Product Code
OLO  
Date Received07/21/2026
Decision Date 08/20/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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