Cleared Special

Intraosseous Fixation System

K201556 · Extremity Medical, LLC · Orthopedic
Jul 2020
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K201556 is an FDA 510(k) clearance for the Intraosseous Fixation System, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Extremity Medical, LLC (Parsippany, US). The FDA issued a Cleared decision on July 8, 2020, 28 days after receiving the submission on June 10, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K201556 FDA.gov
FDA Decision Cleared SESE
Date Received June 10, 2020
Decision Date July 08, 2020
Days to Decision 28 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HWC — Screw, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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