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FDA 510(k)

Stratum™ Reduced Size Foot Plating System

K-Number: K200785 · 2020-07-27

ApplicantNextremity Solutions, Inc.
Decision Date2020-07-27
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Stratum™ Reduced Size Foot Plating System is a medical device manufactured by Nextremity Solutions, Inc.. It received FDA 510(k) clearance on 2020-07-27 under approval number K200785. 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™ Reduced Size Foot Plating System?

Stratum™ Reduced Size Foot Plating System is a medical device that received FDA 510(k) clearance on 2020-07-27. It is manufactured by Nextremity Solutions, Inc.. The 510(k) number is K200785.

When was Stratum™ Reduced Size Foot Plating System approved by the FDA?

Stratum™ Reduced Size Foot Plating System received FDA 510(k) clearance on 2020-07-27, under approval number K200785.

What company makes Stratum™ Reduced Size Foot Plating System?

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

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

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

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Official Source

View on FDA Database →

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

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