Cleared Traditional

Anatomical Plating System (various)

K232652 · Tyber Medical, LLC · Orthopedic
Dec 2023
Decision
104d
Days
Class 2
Risk

About This 510(k) Submission

K232652 is an FDA 510(k) clearance for the Anatomical Plating System (various), 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 13, 2023, 104 days after receiving the submission on August 31, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K232652 FDA.gov
FDA Decision Cleared SESE
Date Received August 31, 2023
Decision Date December 13, 2023
Days to Decision 104 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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