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FDA 510(k)

OMNIBotics Knee System

K-Number: K163338 · 2017-09-01

Decision Date2017-09-01
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

OMNIBotics Knee System is a medical device manufactured by Omnllife Science, Inc.. It received FDA 510(k) clearance on 2017-09-01 under approval number K163338. 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 2017-09-01. It is manufactured by Omnllife Science, Inc.. The 510(k) number is K163338.

When was OMNIBotics Knee System approved by the FDA?

OMNIBotics Knee System received FDA 510(k) clearance on 2017-09-01, under approval number K163338.

What company makes OMNIBotics Knee System?

OMNIBotics Knee System is manufactured by Omnllife Science, Inc..

What is the FDA product code for OMNIBotics Knee System?

The FDA product code for OMNIBotics Knee System is OLO.

Related Devices (Code: OLO)

Official Source

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