Cleared Traditional

VariAx 2 Distal Radius System, VariAx 2 Distal Ulna System

K212581 · Stryker GmbH · Orthopedic
Jan 2022
Decision
156d
Days
Class 2
Risk

About This 510(k) Submission

K212581 is an FDA 510(k) clearance for the VariAx 2 Distal Radius System, VariAx 2 Distal Ulna System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Stryker GmbH (Malwah, US). The FDA issued a Cleared decision on January 19, 2022, 156 days after receiving the submission on August 16, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K212581 FDA.gov
FDA Decision Cleared SESE
Date Received August 16, 2021
Decision Date January 19, 2022
Days to Decision 156 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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