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FDA 510(k)

AxSOS 3Ti

K-Number: K153379 · 2016-05-26

ApplicantStryker GmbH
Decision Date2016-05-26
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AxSOS 3Ti is the device name listed in this FDA 510(k) record. The listed applicant is Stryker GmbH. It received FDA 510(k) clearance on 2016-05-26 under 510(k) number K153379. 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 AxSOS 3Ti?

AxSOS 3Ti is a medical device that received FDA 510(k) clearance on 2016-05-26. The listed applicant is Stryker GmbH. The 510(k) number is K153379.

When did AxSOS 3Ti receive FDA 510(k) clearance?

AxSOS 3Ti received FDA 510(k) clearance on 2016-05-26, under 510(k) number K153379.

Who is the listed applicant for AxSOS 3Ti?

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 AxSOS 3Ti?

The FDA product code for AxSOS 3Ti 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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