Cleared Special

OsteoCentric? UnifiMI? TCS Plating System

K251913 · OsteoCentric Technologies · Orthopedic
Aug 2025
Decision
54d
Days
Class 2
Risk

About This 510(k) Submission

K251913 is an FDA 510(k) clearance for the OsteoCentric? UnifiMI? TCS Plating System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by OsteoCentric Technologies (Logan, US). The FDA issued a Cleared decision on August 16, 2025, 54 days after receiving the submission on June 23, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K251913 FDA.gov
FDA Decision Cleared SESE
Date Received June 23, 2025
Decision Date August 16, 2025
Days to Decision 54 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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