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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 K252880
Device Name Pytheas Your Guided Trajectory
Applicant
Pytheas Navigation Sas
320, Ave. Du Prado
Marseille,  FR 13008
Applicant Contact Marc Forman
Correspondent
Pytheas Navigation Sas
320, Ave. Du Prado
Marseille,  FR 13008
Correspondent Contact Camille Chavy
Regulation Number882.4560
Classification Product Code
OLO  
Subsequent Product Code
OWB  
Date Received09/10/2025
Decision Date 05/11/2026
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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