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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
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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