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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K211386
Device Name MySpine WebPlanner & MyBalance
Applicant
Medacta International S.A.
Strada Regina
Castel San Pietro (Ch),  CH CH-6874
Applicant Contact Stefano Baj
Correspondent
Medacta USA
3973 Delp St.
Memphis,  TN  83118
Correspondent Contact Chris Lussier
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/05/2021
Decision Date 07/23/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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