Cleared Traditional

Tyber Medical Anatomical Plating System

K242486 · Tyber Medical, LLC · Orthopedic
Mar 2025
Decision
210d
Days
Class 2
Risk

About This 510(k) Submission

K242486 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 March 19, 2025, 210 days after receiving the submission on August 21, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K242486 FDA.gov
FDA Decision Cleared SESE
Date Received August 21, 2024
Decision Date March 19, 2025
Days to Decision 210 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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