Cleared Traditional

Tyber Medical Trauma Screw

K153575 · Tyber Medical, LLC · Orthopedic
Feb 2016
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K153575 is an FDA 510(k) clearance for the Tyber Medical 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 February 26, 2016, 73 days after receiving the submission on December 15, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K153575 FDA.gov
FDA Decision Cleared SESE
Date Received December 15, 2015
Decision Date February 26, 2016
Days to Decision 73 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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