Cleared Traditional

Tyber Medical Anatomical Plating System ? Line extension to the Mini-Frag System

K233423 · Tyber Medical, LLC · Orthopedic
Dec 2023
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K233423 is an FDA 510(k) clearance for the Tyber Medical Anatomical Plating System ? Line extension to the Mini-Frag 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 December 21, 2023, 72 days after receiving the submission on October 10, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K233423 FDA.gov
FDA Decision Cleared SESE
Date Received October 10, 2023
Decision Date December 21, 2023
Days to Decision 72 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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