Cleared Traditional

VARIAX DISTAL RADIUS PLATING SYSTEM

K141430 · Stryker Leibinger GmbH & Co KG · Orthopedic
Jul 2014
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K141430 is an FDA 510(k) clearance for the VARIAX DISTAL RADIUS PLATING SYSTEM, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Stryker Leibinger GmbH & Co KG (Malwah, US). The FDA issued a Cleared decision on July 18, 2014, 49 days after receiving the submission on May 30, 2014. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K141430 FDA.gov
FDA Decision Cleared SESE
Date Received May 30, 2014
Decision Date July 18, 2014
Days to Decision 49 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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