Cleared Traditional

K221221 - Advanced Intramedullary Nail System (FDA 510(k) Clearance)

K221221 · Double Medical Technology, Inc. · Orthopedic device

Dec 2022

Decision

238d

Days

Class 2

Risk

K221221 is an FDA 510(k) clearance for the Advanced Intramedullary Nail System. This device is classified as 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 FDA review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number	K221221 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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