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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 K232280
Device Name NextAR™ TSA Platform
Applicant
Medacta International S.A.
Strada Regina
Castel San Pietro,  CH CH-6874
Applicant Contact Stefano Baj
Correspondent
Medacta USA
3973 Delp Street
Memphis,  TN  38118
Correspondent Contact Chris Lussier
Regulation Number882.4560
Classification Product Code
OLO  
Subsequent Product Codes
LLZ   PBF   PHX  
Date Received07/31/2023
Decision Date 10/29/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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