Cleared Special

TriMed Threaded Intramedullary Nail System

K234040 · TriMed, Inc. · Orthopedic
Jan 2024
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K234040 is an FDA 510(k) clearance for the TriMed Threaded Intramedullary Nail System, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by TriMed, Inc. (Valencia, US). The FDA issued a Cleared decision on January 18, 2024, 28 days after receiving the submission on December 21, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K234040 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 2023
Decision Date January 18, 2024
Days to Decision 28 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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