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FDA 510(k)

VariAx Distal Radius Plating System, VariAx 2 System

K-Number: K162841 · 2017-02-21

ApplicantStryker GmbH
Decision Date2017-02-21
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VariAx Distal Radius Plating System, VariAx 2 System is a medical device manufactured by Stryker GmbH. It received FDA 510(k) clearance on 2017-02-21 under approval number K162841. 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 VariAx Distal Radius Plating System, VariAx 2 System?

VariAx Distal Radius Plating System, VariAx 2 System is a medical device that received FDA 510(k) clearance on 2017-02-21. It is manufactured by Stryker GmbH. The 510(k) number is K162841.

When was VariAx Distal Radius Plating System, VariAx 2 System approved by the FDA?

VariAx Distal Radius Plating System, VariAx 2 System received FDA 510(k) clearance on 2017-02-21, under approval number K162841.

What company makes VariAx Distal Radius Plating System, VariAx 2 System?

VariAx Distal Radius Plating System, VariAx 2 System is manufactured by Stryker GmbH.

What is the FDA product code for VariAx Distal Radius Plating System, VariAx 2 System?

The FDA product code for VariAx Distal Radius Plating System, VariAx 2 System is HRS.

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Related Devices (Code: 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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