Cleared Traditional

Tyber Medical Distal Radius Plating System

K232693 · Tyber Medical, LLC · Orthopedic
Dec 2023
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K232693 is an FDA 510(k) clearance for the Tyber Medical Distal Radius 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 December 4, 2023, 90 days after receiving the submission on September 5, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K232693 FDA.gov
FDA Decision Cleared SESE
Date Received September 05, 2023
Decision Date December 04, 2023
Days to Decision 90 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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