Cleared Abbreviated

CanMINI Hand and Foot System

K242973 · Canwell Medical Co., Ltd. · Orthopedic

Apr 2025

Decision

210d

Days

Class 2

Risk

About This 510(k) Submission

K242973 is an FDA 510(k) clearance for the CanMINI Hand and Foot System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Canwell Medical Co., Ltd. (Jinhua, CN). The FDA issued a Cleared decision on April 24, 2025, 210 days after receiving the submission on September 26, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K242973 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 26, 2024
Decision Date	April 24, 2025
Days to Decision	210 days
Submission Type	Abbreviated
Review Panel	Orthopedic (OR)
Summary	Summary PDF