Cleared Traditional

Treace Medical Concepts (TMC) Compression Screw System

K172617 · Treace Medical Concepts, Inc. · Orthopedic
Oct 2017
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K172617 is an FDA 510(k) clearance for the Treace Medical Concepts (TMC) Compression Screw System, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Treace Medical Concepts, Inc. (Ponte Vedra Beach, US). The FDA issued a Cleared decision on October 25, 2017, 55 days after receiving the submission on August 31, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K172617 FDA.gov
FDA Decision Cleared SESE
Date Received August 31, 2017
Decision Date October 25, 2017
Days to Decision 55 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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