Cleared Special

Extremity Medical External Fixation System

K251128 · Extremity Medical, LLC · Orthopedic

May 2025

Decision

26d

Days

Class 2

Risk

About This 510(k) Submission

K251128 is an FDA 510(k) clearance for the Extremity Medical External Fixation System, a Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (Class II — Special Controls, product code KTT), submitted by Extremity Medical, LLC (Parsippany, US). The FDA issued a Cleared decision on May 7, 2025, 26 days after receiving the submission on April 11, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K251128 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 11, 2025
Decision Date	May 07, 2025
Days to Decision	26 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	KTT — Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3030