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FDA 510(k)

AutoStrut G2

K-Number: K202810 · 2021-01-06

ApplicantOrthospin, Ltd.
Decision Date2021-01-06
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AutoStrut G2 is a medical device manufactured by Orthospin, Ltd.. It received FDA 510(k) clearance on 2021-01-06 under approval number K202810. 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 G2?

AutoStrut G2 is a medical device that received FDA 510(k) clearance on 2021-01-06. It is manufactured by Orthospin, Ltd.. The 510(k) number is K202810.

When was AutoStrut G2 approved by the FDA?

AutoStrut G2 received FDA 510(k) clearance on 2021-01-06, under approval number K202810.

What company makes AutoStrut G2?

AutoStrut G2 is manufactured by Orthospin, Ltd..

What is the FDA product code for AutoStrut G2?

The FDA product code for AutoStrut G2 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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