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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
Corin Ltd.
480 Paramount Drive
raynham,  MA  02767
Applicant Contact christina rovaldi
Bio Vera Inc.
65 Promenade Saint Louis
notre dame de lile perrot,  CA j7v7p2
Correspondent Contact robert a. poggie
Regulation Number882.4560
Classification Product Code
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