Cleared Special

Axis Charcot Fixation System

K211261 · Extremity Medical, LLC · Orthopedic
May 2021
Decision
32d
Days
Class 2
Risk

About This 510(k) Submission

K211261 is an FDA 510(k) clearance for the Axis Charcot 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 May 28, 2021, 32 days after receiving the submission on April 26, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K211261 FDA.gov
FDA Decision Cleared SESE
Date Received April 26, 2021
Decision Date May 28, 2021
Days to Decision 32 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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