Cleared Traditional

VariAx 2 Distal Radius System

K233919 · Stryker GmbH · Orthopedic
Mar 2024
Decision
103d
Days
Class 2
Risk

About This 510(k) Submission

K233919 is an FDA 510(k) clearance for the VariAx 2 Distal Radius System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Stryker GmbH (Selzach, Solothurn, Ch, CH). The FDA issued a Cleared decision on March 25, 2024, 103 days after receiving the submission on December 13, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K233919 FDA.gov
FDA Decision Cleared SESE
Date Received December 13, 2023
Decision Date March 25, 2024
Days to Decision 103 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HRS — Plate, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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