OMNIBotics Knee System

Orthopedic Stereotaxic Instrument

Corin Ltd.

The following data is part of a premarket notification filed by Corin Ltd. with the FDA for Omnibotics Knee System.

Pre-market Notification Details

Device IDK200888
510k NumberK200888
Device Name:OMNIBotics Knee System
ClassificationOrthopedic Stereotaxic Instrument
Applicant Corin Ltd. 480 Paramount Drive Raynham,  MA  02767
ContactChristina Rovaldi
CorrespondentRobert A. Poggie
Bio Vera Inc. 65 Promenade Saint Louis Notre Dame De Lile Perrot,  CA J7v7p2
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-03
Decision Date2020-06-27

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