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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 K260240
Device Name SYMPHONY Navigation Ready Instruments
Applicant
Medos International SARL
Chemin-Blanc 38
Le Locle,  CH 2400
Applicant Contact Sophia Chang
Correspondent
Depuy Synthes
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact Sophia Chang
Regulation Number882.4560
Classification Product Code
OLO  
Date Received01/26/2026
Decision Date 03/27/2026
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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