Cleared Traditional

Tyber Medical Anatomical Plating System

K222465 · Tyber Medical, LLC · Orthopedic
Mar 2023
Decision
204d
Days
Class 2
Risk

About This 510(k) Submission

K222465 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 7, 2023, 204 days after receiving the submission on August 15, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K222465 FDA.gov
FDA Decision Cleared SESE
Date Received August 15, 2022
Decision Date March 07, 2023
Days to Decision 204 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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