Cleared Traditional

EasyClip? and EasyClip? Xpress

K210582 · Stryker GmbH · Orthopedic
Jun 2022
Decision
469d
Days
Class 2
Risk

About This 510(k) Submission

K210582 is an FDA 510(k) clearance for the EasyClip? and EasyClip? Xpress, a Staple, Fixation, Bone (Class II — Special Controls, product code JDR), submitted by Stryker GmbH (Malwah, US). The FDA issued a Cleared decision on June 10, 2022, 469 days after receiving the submission on February 26, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K210582 FDA.gov
FDA Decision Cleared SESE
Date Received February 26, 2021
Decision Date June 10, 2022
Days to Decision 469 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JDR — Staple, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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