Cleared Traditional

REDEMPTION Beaming System

K221342 · Vilex, LLC · Orthopedic
Dec 2022
Decision
218d
Days
Class 2
Risk

About This 510(k) Submission

K221342 is an FDA 510(k) clearance for the REDEMPTION Beaming System, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Vilex, LLC (Mcminnville, US). The FDA issued a Cleared decision on December 13, 2022, 218 days after receiving the submission on May 9, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K221342 FDA.gov
FDA Decision Cleared SESE
Date Received May 09, 2022
Decision Date December 13, 2022
Days to Decision 218 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HWC — Screw, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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