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FDA 510(k)

EasyStep

K-Number: K160813 · 2016-07-26

ApplicantStryker GmbH
Decision Date2016-07-26
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EasyStep is the device name listed in this FDA 510(k) record. The listed applicant is Stryker GmbH. It received FDA 510(k) clearance on 2016-07-26 under 510(k) number K160813. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EasyStep?

EasyStep is a medical device that received FDA 510(k) clearance on 2016-07-26. The listed applicant is Stryker GmbH. The 510(k) number is K160813.

When did EasyStep receive FDA 510(k) clearance?

EasyStep received FDA 510(k) clearance on 2016-07-26, under 510(k) number K160813.

Who is the listed applicant for EasyStep?

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 EasyStep?

The FDA product code for EasyStep is JDR.

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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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