EasyClip® And EasyClip® Xpress

Staple, Fixation, Bone

Stryker GmbH

The following data is part of a premarket notification filed by Stryker Gmbh with the FDA for Easyclip® And Easyclip® Xpress.

Pre-market Notification Details

• Device ID: K210582
• 510k Number: K210582
• Device Name: EasyClip® And EasyClip® Xpress
• Classification: Staple, Fixation, Bone
• Applicant: Stryker GmbH 325 Corporate Drive Mahwah, NJ 07430
• Contact: Danielle Jannuzzi Madureira
• Correspondent: Danielle Jannuzzi Madureira; Stryker GmbH 325 Corporate Drive Mahwah, NJ 07430
• Product Code: JDR
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-02-26
• Decision Date: 2022-06-10