FDA 510(k)

Stratum Foot Plating System

K-Number: K182201 · 2018-11-16

Decision Date2018-11-16

Product CodeHRS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Stratum Foot Plating System is a medical device manufactured by Nextremity Solutions, Inc.. It received FDA 510(k) clearance on 2018-11-16 under approval number K182201. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stratum Foot Plating System?

Stratum Foot Plating System is a medical device that received FDA 510(k) clearance on 2018-11-16. It is manufactured by Nextremity Solutions, Inc.. The 510(k) number is K182201.

When was Stratum Foot Plating System approved by the FDA?

Stratum Foot Plating System received FDA 510(k) clearance on 2018-11-16, under approval number K182201.

What company makes Stratum Foot Plating System?

Stratum Foot Plating System is manufactured by Nextremity Solutions, Inc..

What is the FDA product code for Stratum Foot Plating System?

The FDA product code for Stratum Foot Plating System is HRS.

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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.