Cleared Traditional

Redemption Duo Hindfoot Nail System

K231343 · Vilex, LLC · Orthopedic
Jan 2024
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K231343 is an FDA 510(k) clearance for the Redemption Duo Hindfoot Nail System, a Rod, Fixation, Intramedullary And Accessories (Class II — Special Controls, product code HSB), submitted by Vilex, LLC (Mcminnville, US). The FDA issued a Cleared decision on January 30, 2024, 266 days after receiving the submission on May 9, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number K231343 FDA.gov
FDA Decision Cleared SESE
Date Received May 09, 2023
Decision Date January 30, 2024
Days to Decision 266 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HSB — Rod, Fixation, Intramedullary And Accessories
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3020

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