Cleared Traditional

Acumed Wrist Plating System

K233311 · Acumed, LLC · Orthopedic
Apr 2024
Decision
206d
Days
Class 2
Risk

About This 510(k) Submission

K233311 is an FDA 510(k) clearance for the Acumed Wrist Plating System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Acumed, LLC (Hillsboro, US). The FDA issued a Cleared decision on April 22, 2024, 206 days after receiving the submission on September 29, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K233311 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2023
Decision Date April 22, 2024
Days to Decision 206 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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