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FDA 510(k)

VariAx 2 Distal Radius System

K-Number: K233919 · 2024-03-25

ApplicantStryker GmbH
Decision Date2024-03-25
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VariAx 2 Distal Radius 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 2024-03-25 under 510(k) number K233919. 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 2 Distal Radius System?

VariAx 2 Distal Radius System is a medical device that received FDA 510(k) clearance on 2024-03-25. The listed applicant is Stryker GmbH. The 510(k) number is K233919.

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

VariAx 2 Distal Radius System received FDA 510(k) clearance on 2024-03-25, under 510(k) number K233919.

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

The FDA product code for VariAx 2 Distal Radius 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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