VariAx 2 Foot System
K-Number: K170771 · 2017-05-08
ApplicantStryker GmbH
Decision Date2017-05-08
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
VariAx 2 Foot System is a medical device manufactured by Stryker GmbH. It received FDA 510(k) clearance on 2017-05-08 under approval number K170771. 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 Foot System?
VariAx 2 Foot System is a medical device that received FDA 510(k) clearance on 2017-05-08. It is manufactured by Stryker GmbH. The 510(k) number is K170771.
When was VariAx 2 Foot System approved by the FDA?
VariAx 2 Foot System received FDA 510(k) clearance on 2017-05-08, under approval number K170771.
What company makes VariAx 2 Foot System?
VariAx 2 Foot System is manufactured by Stryker GmbH.
What is the FDA product code for VariAx 2 Foot System?
The FDA product code for VariAx 2 Foot 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.