Cleared Traditional

ALPHALOK Plating System

K230204 · Vilex, LLC · Orthopedic
Apr 2023
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K230204 is an FDA 510(k) clearance for the ALPHALOK Plating System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Vilex, LLC (Mcminnville, US). The FDA issued a Cleared decision on April 25, 2023, 90 days after receiving the submission on January 25, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K230204 FDA.gov
FDA Decision Cleared SESE
Date Received January 25, 2023
Decision Date April 25, 2023
Days to Decision 90 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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