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FDA 510(k)

VariAx 2 Distal Radius System, VariAx 2 Distal Ulna System

K-Number: K212581 · 2022-01-19

ApplicantStryker GmbH
Decision Date2022-01-19
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VariAx 2 Distal Radius System, VariAx 2 Distal Ulna 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 2022-01-19 under 510(k) number K212581. 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 Ulna System?

VariAx 2 Distal Radius System, VariAx 2 Distal Ulna System is a medical device that received FDA 510(k) clearance on 2022-01-19. The listed applicant is Stryker GmbH. The 510(k) number is K212581.

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

VariAx 2 Distal Radius System, VariAx 2 Distal Ulna System received FDA 510(k) clearance on 2022-01-19, under 510(k) number K212581.

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

The FDA product code for VariAx 2 Distal Radius System, VariAx 2 Distal Ulna 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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