FDA 510(k)

OMNIBotics Knee System

K-Number: K200888 · 2020-06-27

Decision Date2020-06-27

Product CodeOLO

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

OMNIBotics Knee System is a medical device manufactured by Corin, Ltd.. It received FDA 510(k) clearance on 2020-06-27 under approval number K200888. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNIBotics Knee System?

OMNIBotics Knee System is a medical device that received FDA 510(k) clearance on 2020-06-27. It is manufactured by Corin, Ltd.. The 510(k) number is K200888.

When was OMNIBotics Knee System approved by the FDA?

OMNIBotics Knee System received FDA 510(k) clearance on 2020-06-27, under approval number K200888.

What company makes OMNIBotics Knee System?

OMNIBotics Knee System is manufactured by Corin, Ltd..

What is the FDA product code for OMNIBotics Knee System?

The FDA product code for OMNIBotics Knee System is OLO.

Other Devices by Corin, Ltd.

K201657Corin Ltd. Hip Products: Trinity Acetabular System, Trinity PLUS Acetabular Shell, MetaFix Hip System, TriFit CF and TS Hip Systems, TaperFit Hip System, Revival Modular Hip System, MiniHip, Trinity Dual Mobility, MobiliT, BiPolar-i, OMNI MOD Hip System, OMNI K1 and K2 Hip Systems, OMNI Bipolar Heads, Corin Biolox Delta Ceramic Heads, OMNI Delta Ceramic Heads

Related Devices (Code: OLO)

K162375Envision 3D: Image Guidance System7D Surgical, Inc. K162341Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc. K160385Precision ScrewCryptych Pty, Ltd. K153700Aesculap(R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC K153240Styrker OrthoMap Express Knee SystemStryker Corporate

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.