Cleared Traditional

REDEMPTION Charcot Plating System

K233816 · Vilex, LLC · Orthopedic
Aug 2024
Decision
272d
Days
Class 2
Risk

About This 510(k) Submission

K233816 is an FDA 510(k) clearance for the REDEMPTION Charcot 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 August 28, 2024, 272 days after receiving the submission on November 30, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K233816 FDA.gov
FDA Decision Cleared SESE
Date Received November 30, 2023
Decision Date August 28, 2024
Days to Decision 272 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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