Cleared Traditional

TITANEX? MICROBEAM Screw System, TITANEX? ARTEMIS Screw System

K231504 · Vilex, LLC · Orthopedic
Sep 2023
Decision
110d
Days
Class 2
Risk

About This 510(k) Submission

K231504 is an FDA 510(k) clearance for the TITANEX? MICROBEAM Screw System, TITANEX? ARTEMIS Screw 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 September 11, 2023, 110 days after receiving the submission on May 24, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K231504 FDA.gov
FDA Decision Cleared SESE
Date Received May 24, 2023
Decision Date September 11, 2023
Days to Decision 110 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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