Cleared Traditional

Tyber Medical Trauma Screw

K192974 · Tyber Medical, LLC · Orthopedic
Jan 2020
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K192974 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 (Bethlehem, US). The FDA issued a Cleared decision on January 8, 2020, 76 days after receiving the submission on October 24, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K192974 FDA.gov
FDA Decision Cleared SESE
Date Received October 24, 2019
Decision Date January 08, 2020
Days to Decision 76 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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