Cleared Traditional

Tyber Medical Anatomical Plating System

K203817 · Tyber Medical, LLC · Orthopedic
Aug 2021
Decision
227d
Days
Class 2
Risk

About This 510(k) Submission

K203817 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 August 13, 2021, 227 days after receiving the submission on December 29, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K203817 FDA.gov
FDA Decision Cleared SESE
Date Received December 29, 2020
Decision Date August 13, 2021
Days to Decision 227 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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