Cleared Special

Tyber Medical MST Trauma Screw

K153180 · Tyber Medical, LLC · Orthopedic
Nov 2015
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K153180 is an FDA 510(k) clearance for the Tyber Medical MST Trauma Screw, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Tyber Medical, LLC (Morristown, US). The FDA issued a Cleared decision on November 25, 2015, 22 days after receiving the submission on November 3, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K153180 FDA.gov
FDA Decision Cleared SESE
Date Received November 03, 2015
Decision Date November 25, 2015
Days to Decision 22 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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