Cleared Traditional

TriMed Humeral Supracondylar Fixation System

K151735 · TriMed, Inc. · Orthopedic
Jan 2016
Decision
217d
Days
Class 2
Risk

About This 510(k) Submission

K151735 is an FDA 510(k) clearance for the TriMed Humeral Supracondylar 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 January 29, 2016, 217 days after receiving the submission on June 26, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K151735 FDA.gov
FDA Decision Cleared SESE
Date Received June 26, 2015
Decision Date January 29, 2016
Days to Decision 217 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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