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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 K253604
Device Name TiLink-L Navigation Instruments
Applicant
SurGenTec, LLC
911 Clint Moore Rd.
Boca Raton,  FL  33487
Applicant Contact Richard Sharp
Correspondent
SurGenTec, LLC
911 Clint Moore Rd.
Boca Raton,  FL  33487
Correspondent Contact Richard Sharp
Regulation Number882.4560
Classification Product Code
OLO  
Date Received11/18/2025
Decision Date 03/20/2026
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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