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FDA 510(k)

Styrker OrthoMap Express Knee System

K-Number: K153240 · 2016-07-07

Decision Date2016-07-07
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Styrker OrthoMap Express Knee System is a medical device manufactured by Stryker Corporate. It received FDA 510(k) clearance on 2016-07-07 under approval number K153240. 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 Styrker OrthoMap Express Knee System?

Styrker OrthoMap Express Knee System is a medical device that received FDA 510(k) clearance on 2016-07-07. It is manufactured by Stryker Corporate. The 510(k) number is K153240.

When was Styrker OrthoMap Express Knee System approved by the FDA?

Styrker OrthoMap Express Knee System received FDA 510(k) clearance on 2016-07-07, under approval number K153240.

What company makes Styrker OrthoMap Express Knee System?

Styrker OrthoMap Express Knee System is manufactured by Stryker Corporate.

What is the FDA product code for Styrker OrthoMap Express Knee System?

The FDA product code for Styrker OrthoMap Express Knee System is OLO.

Related Clinical Trials

Related Devices (Code: OLO)

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.