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FDA 510(k)

Smart Toe II, X Fuse

K-Number: K201715 · 2020-08-05

ApplicantStryker GmbH
Decision Date2020-08-05
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Smart Toe II, X Fuse is the device name listed in this FDA 510(k) record. The listed applicant is Stryker GmbH. It received FDA 510(k) clearance on 2020-08-05 under 510(k) 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. The listed applicant is Stryker GmbH. The 510(k) number is K201715.

When did Smart Toe II, X Fuse receive FDA 510(k) clearance?

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

Who is the listed applicant for Smart Toe II, X Fuse?

The FDA 510(k) record lists Stryker GmbH as the applicant. This does not by itself establish the device manufacturer.

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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