Cleared Traditional

TriMed Threaded Intramedullary Nail System

K211783 · TriMed, Inc. · Orthopedic
Aug 2021
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K211783 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 August 6, 2021, 58 days after receiving the submission on June 9, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K211783 FDA.gov
FDA Decision Cleared SESE
Date Received June 09, 2021
Decision Date August 06, 2021
Days to Decision 58 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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