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FDA 510(k)

VariAx 2 System, VariAx 2 Mini Fragment System

K-Number: K191412 · 2019-08-23

ApplicantStryker GmbH
Decision Date2019-08-23
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VariAx 2 System, VariAx 2 Mini Fragment System is a medical device manufactured by Stryker GmbH. It received FDA 510(k) clearance on 2019-08-23 under approval number K191412. 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 System, VariAx 2 Mini Fragment System?

VariAx 2 System, VariAx 2 Mini Fragment System is a medical device that received FDA 510(k) clearance on 2019-08-23. It is manufactured by Stryker GmbH. The 510(k) number is K191412.

When was VariAx 2 System, VariAx 2 Mini Fragment System approved by the FDA?

VariAx 2 System, VariAx 2 Mini Fragment System received FDA 510(k) clearance on 2019-08-23, under approval number K191412.

What company makes VariAx 2 System, VariAx 2 Mini Fragment System?

VariAx 2 System, VariAx 2 Mini Fragment System is manufactured by Stryker GmbH.

What is the FDA product code for VariAx 2 System, VariAx 2 Mini Fragment System?

The FDA product code for VariAx 2 System, VariAx 2 Mini Fragment 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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