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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 K200888
Device Name OMNIBotics Knee System
Applicant
Corin, Ltd.
480 Paramount Dr.
Raynham,  MA  02767
Applicant Contact Christina Rovaldi
Correspondent
BioVera, Inc.
65 Promenade Saint Louis
Notre-Dame-De-L'Ile Perrot,  CA J7V 7P2
Correspondent Contact Robert A. Poggie
Regulation Number882.4560
Classification Product Code
OLO  
Date Received04/03/2020
Decision Date 06/27/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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