Cleared Traditional

Tyber Medical Distal Radius Plating System

K251361 · Tyber Medical, LLC · Orthopedic
Jul 2025
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K251361 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 July 30, 2025, 90 days after receiving the submission on May 1, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K251361 FDA.gov
FDA Decision Cleared SESE
Date Received May 01, 2025
Decision Date July 30, 2025
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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