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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 the device name listed in this FDA 510(k) record. The listed applicant is Stryker GmbH. It received FDA 510(k) clearance on 2017-02-21 under 510(k) 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. The listed applicant is Stryker GmbH. The 510(k) number is K162841.

When did VariAx Distal Radius Plating System, VariAx 2 System receive FDA 510(k) clearance?

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

Who is the listed applicant for VariAx Distal Radius Plating System, VariAx 2 System?

The FDA 510(k) record lists Stryker GmbH as the applicant. This does not by itself establish the device manufacturer.

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)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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