FDA 510(k)

AxSOS 3 Ti

K-Number: K172350 · 2017-12-15

Decision Date2017-12-15

Product CodeHRS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

AxSOS 3 Ti is a medical device manufactured by Stryker GmbH. It received FDA 510(k) clearance on 2017-12-15 under approval number K172350. 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 3 Ti?

AxSOS 3 Ti is a medical device that received FDA 510(k) clearance on 2017-12-15. It is manufactured by Stryker GmbH. The 510(k) number is K172350.

When was AxSOS 3 Ti approved by the FDA?

AxSOS 3 Ti received FDA 510(k) clearance on 2017-12-15, under approval number K172350.

What company makes AxSOS 3 Ti?

AxSOS 3 Ti is manufactured by Stryker GmbH.

What is the FDA product code for AxSOS 3 Ti?

The FDA product code for AxSOS 3 Ti is HRS.

Other Devices by Stryker GmbH

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Related Devices (Code: HRS)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.