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FDA 510(k)

AxSOS 3 AF System and AxSOS 3 Ti System

K-Number: K200398 · 2020-06-05

ApplicantStryker GmbH
Decision Date2020-06-05
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AxSOS 3 AF System and AxSOS 3 Ti System is a medical device manufactured by Stryker GmbH. It received FDA 510(k) clearance on 2020-06-05 under approval number K200398. 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 AF System and AxSOS 3 Ti System?

AxSOS 3 AF System and AxSOS 3 Ti System is a medical device that received FDA 510(k) clearance on 2020-06-05. It is manufactured by Stryker GmbH. The 510(k) number is K200398.

When was AxSOS 3 AF System and AxSOS 3 Ti System approved by the FDA?

AxSOS 3 AF System and AxSOS 3 Ti System received FDA 510(k) clearance on 2020-06-05, under approval number K200398.

What company makes AxSOS 3 AF System and AxSOS 3 Ti System?

AxSOS 3 AF System and AxSOS 3 Ti System is manufactured by Stryker GmbH.

What is the FDA product code for AxSOS 3 AF System and AxSOS 3 Ti System?

The FDA product code for AxSOS 3 AF System and AxSOS 3 Ti 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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