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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 K223108
Device Name TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear)
Applicant
Medos International, SARL
Chemin-Blanc 38
Le Locle,  CH 2400
Applicant Contact Karin McDonough
Correspondent
DePuy Spine
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact Karin McDonough
Regulation Number882.4560
Classification Product Code
OLO  
Subsequent Product Codes
HAW   HRX  
Date Received09/30/2022
Decision Date 01/19/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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