Cleared Traditional

Tyber Medical Anatomical Plating System

K193222 · Tyber Medical, LLC · Orthopedic
Jan 2020
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K193222 is an FDA 510(k) clearance for the Tyber Medical Anatomical Plating System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Tyber Medical, LLC (Bethlehem, US). The FDA issued a Cleared decision on January 20, 2020, 59 days after receiving the submission on November 22, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K193222 FDA.gov
FDA Decision Cleared SESE
Date Received November 22, 2019
Decision Date January 20, 2020
Days to Decision 59 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HRS — Plate, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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