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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 K233254
Device Name TELIGEN System Navigation Ready Instruments
Applicant
DePuy Synthes
Eimattstrasse 3
Oberdorf,  CH 4436
Applicant Contact Marina Minnock
Correspondent
DePuy Synthes
Eimattstrasse 3
Oberdorf,  CH 4436
Correspondent Contact Marina Minnock
Regulation Number882.4560
Classification Product Code
OLO  
Date Received09/28/2023
Decision Date 06/14/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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