Cleared Traditional

Advanced Intramedullary Nail System

K221221 · Double Medical Technology, Inc. · Orthopedic
Dec 2022
Decision
238d
Days
Class 2
Risk

About This 510(k) Submission

K221221 is an FDA 510(k) clearance for the Advanced Intramedullary Nail System, a Rod, Fixation, Intramedullary And Accessories (Class II — Special Controls, product code HSB), submitted by Double Medical Technology, Inc. (Xiamen, CN). The FDA issued a Cleared decision on December 21, 2022, 238 days after receiving the submission on April 27, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number K221221 FDA.gov
FDA Decision Cleared SESE
Date Received April 27, 2022
Decision Date December 21, 2022
Days to Decision 238 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HSB — Rod, Fixation, Intramedullary And Accessories
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3020

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