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FDA 510(k)

Stryker VariAx 2 MIS Calcaneus

K-Number: K221346 · 2022-07-08

ApplicantStryker GmbH
Decision Date2022-07-08
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Stryker VariAx 2 MIS Calcaneus is the device name listed in this FDA 510(k) record. The listed applicant is Stryker GmbH. It received FDA 510(k) clearance on 2022-07-08 under 510(k) number K221346. 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 Stryker VariAx 2 MIS Calcaneus?

Stryker VariAx 2 MIS Calcaneus is a medical device that received FDA 510(k) clearance on 2022-07-08. The listed applicant is Stryker GmbH. The 510(k) number is K221346.

When did Stryker VariAx 2 MIS Calcaneus receive FDA 510(k) clearance?

Stryker VariAx 2 MIS Calcaneus received FDA 510(k) clearance on 2022-07-08, under 510(k) number K221346.

Who is the listed applicant for Stryker VariAx 2 MIS Calcaneus?

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 Stryker VariAx 2 MIS Calcaneus?

The FDA product code for Stryker VariAx 2 MIS Calcaneus 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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