Cleared Special

Tyber Medical Anatomical Plating System

K241218 · Tyber Medical, LLC · Orthopedic
May 2024
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K241218 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 May 31, 2024, 30 days after receiving the submission on May 1, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K241218 FDA.gov
FDA Decision Cleared SESE
Date Received May 01, 2024
Decision Date May 31, 2024
Days to Decision 30 days
Submission Type Special
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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