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FDA 510(k)

Mako Partial Knee Application

K-Number: K170891 · 2017-05-24

Decision Date2017-05-24
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Mako Partial Knee Application is a medical device manufactured by Mako Surgical Corp.. It received FDA 510(k) clearance on 2017-05-24 under approval number K170891. 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 Mako Partial Knee Application?

Mako Partial Knee Application is a medical device that received FDA 510(k) clearance on 2017-05-24. It is manufactured by Mako Surgical Corp.. The 510(k) number is K170891.

When was Mako Partial Knee Application approved by the FDA?

Mako Partial Knee Application received FDA 510(k) clearance on 2017-05-24, under approval number K170891.

What company makes Mako Partial Knee Application?

Mako Partial Knee Application is manufactured by Mako Surgical Corp..

What is the FDA product code for Mako Partial Knee Application?

The FDA product code for Mako Partial Knee Application is OLO.

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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.