Cleared Special

Freefix Forearm Plating System

K242055 · Skeletal Dynamics, Inc. · Orthopedic
Aug 2024
Decision
17d
Days
Class 2
Risk

About This 510(k) Submission

K242055 is an FDA 510(k) clearance for the Freefix Forearm Plating System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Skeletal Dynamics, Inc. (Miami, US). The FDA issued a Cleared decision on August 1, 2024, 17 days after receiving the submission on July 15, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K242055 FDA.gov
FDA Decision Cleared SESE
Date Received July 15, 2024
Decision Date August 01, 2024
Days to Decision 17 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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