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 a medical device manufactured by Stryker GmbH. It received FDA 510(k) clearance on 2016-05-26 under approval 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. It is manufactured by Stryker GmbH. The 510(k) number is K153379.
When was AxSOS 3Ti approved by the FDA?
AxSOS 3Ti received FDA 510(k) clearance on 2016-05-26, under approval number K153379.
What company makes AxSOS 3Ti?
AxSOS 3Ti is manufactured by Stryker GmbH.
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.