Cleared Special

TITANEX Screw Systems

K250304 · Vilex, LLC · Orthopedic
Mar 2025
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K250304 is an FDA 510(k) clearance for the TITANEX Screw Systems, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Vilex, LLC (Mcminnville, US). The FDA issued a Cleared decision on March 5, 2025, 30 days after receiving the submission on February 3, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K250304 FDA.gov
FDA Decision Cleared SESE
Date Received February 03, 2025
Decision Date March 05, 2025
Days to Decision 30 days
Submission Type Special
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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