FDA 510(k)

Smart Toe II, X Fuse

K-Number: K201715 · 2020-08-05

Decision Date2020-08-05

Product CodeHTY

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Smart Toe II, X Fuse is a medical device manufactured by Stryker GmbH. It received FDA 510(k) clearance on 2020-08-05 under approval number K201715. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Smart Toe II, X Fuse?

Smart Toe II, X Fuse is a medical device that received FDA 510(k) clearance on 2020-08-05. It is manufactured by Stryker GmbH. The 510(k) number is K201715.

When was Smart Toe II, X Fuse approved by the FDA?

Smart Toe II, X Fuse received FDA 510(k) clearance on 2020-08-05, under approval number K201715.

What company makes Smart Toe II, X Fuse?

Smart Toe II, X Fuse is manufactured by Stryker GmbH.

What is the FDA product code for Smart Toe II, X Fuse?

The FDA product code for Smart Toe II, X Fuse is HTY.

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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.