Cleared Special

The Acumed Wrist Fixation System - 2.4mm Screws

K252356 · Acumed, LLC · Orthopedic
Aug 2025
Decision
23d
Days
Class 2
Risk

About This 510(k) Submission

K252356 is an FDA 510(k) clearance for the The Acumed Wrist Fixation System - 2.4mm Screws, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Acumed, LLC (Hillsboro, US). The FDA issued a Cleared decision on August 21, 2025, 23 days after receiving the submission on July 29, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K252356 FDA.gov
FDA Decision Cleared SESE
Date Received July 29, 2025
Decision Date August 21, 2025
Days to Decision 23 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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