FDA 510(k)

AxSOS 3 Ti

K-Number: K181091 · 2018-10-11

Decision Date2018-10-11

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 2018-10-11 under approval number K181091. 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 2018-10-11. It is manufactured by Stryker GmbH. The 510(k) number is K181091.

When was AxSOS 3 Ti approved by the FDA?

AxSOS 3 Ti received FDA 510(k) clearance on 2018-10-11, under approval number K181091.

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

K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA) K161753Hoffman LRF System K160813EasyStep K153379AxSOS 3Ti K153377Hoffmann LRF (Limb Reconstruction Frame) System K172350AxSOS 3 Ti

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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.