FDA 510(k)

EasyClip® and EasyClip® Xpress

K-Number: K210582 · 2022-06-10

Decision Date2022-06-10

Product CodeJDR

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

EasyClip® and EasyClip® Xpress is a medical device manufactured by Stryker GmbH. It received FDA 510(k) clearance on 2022-06-10 under approval number K210582. 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 EasyClip® and EasyClip® Xpress?

EasyClip® and EasyClip® Xpress is a medical device that received FDA 510(k) clearance on 2022-06-10. It is manufactured by Stryker GmbH. The 510(k) number is K210582.

When was EasyClip® and EasyClip® Xpress approved by the FDA?

EasyClip® and EasyClip® Xpress received FDA 510(k) clearance on 2022-06-10, under approval number K210582.

What company makes EasyClip® and EasyClip® Xpress?

EasyClip® and EasyClip® Xpress is manufactured by Stryker GmbH.

What is the FDA product code for EasyClip® and EasyClip® Xpress?

The FDA product code for EasyClip® and EasyClip® Xpress is JDR.

Other Devices by Stryker GmbH

K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA) K161753Hoffman LRF System K160813EasyStep K153379AxSOS 3Ti K153377Hoffmann LRF (Limb Reconstruction Frame) System K172350AxSOS 3 Ti

View all 52 devices →

Related Devices (Code: JDR)

K161426NeoSpan Compression Staple Impant w/instrumentsIn2bones USA, LLC K160813EasyStepStryker GmbH K153622First Ray Internal Bone Staple SystemFirst Ray, LLC K153770OS2(R)-VP Varisation StapleIn2bones Sas K153395OS2-C Compression StapleIn2bones Sas K153129dynaMX Tabbed StapleMx Orthopedics, Corp.

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.