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FDA 510(k)

AutoStrut

K-Number: K191241 · 2019-08-14

ApplicantOrthospin
Decision Date2019-08-14
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AutoStrut is a medical device manufactured by Orthospin. It received FDA 510(k) clearance on 2019-08-14 under approval number K191241. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AutoStrut?

AutoStrut is a medical device that received FDA 510(k) clearance on 2019-08-14. It is manufactured by Orthospin. The 510(k) number is K191241.

When was AutoStrut approved by the FDA?

AutoStrut received FDA 510(k) clearance on 2019-08-14, under approval number K191241.

What company makes AutoStrut?

AutoStrut is manufactured by Orthospin.

What is the FDA product code for AutoStrut?

The FDA product code for AutoStrut is KTT.

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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.

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