Cleared Traditional

TriMed Posterior Malleolus Fixation System

K243050 · TriMed, Inc. · Orthopedic
Nov 2024
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K243050 is an FDA 510(k) clearance for the TriMed Posterior Malleolus Fixation System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by TriMed, Inc. (Valencia, US). The FDA issued a Cleared decision on November 26, 2024, 60 days after receiving the submission on September 27, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K243050 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 2024
Decision Date November 26, 2024
Days to Decision 60 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HRS — Plate, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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