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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 K202152
Device Name NextAR TKA Platform
Applicant
Medacta International SA
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 Code
JWH  
Date Received08/03/2020
Decision Date 10/27/2020
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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