FDA 510(k)

CanMINI Hand and Foot System

K-Number: K242973 · 2025-04-24

Decision Date2025-04-24

Product CodeHRS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

CanMINI Hand and Foot System is a medical device manufactured by Canwell Medical Co., Ltd.. It received FDA 510(k) clearance on 2025-04-24 under approval number K242973. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CanMINI Hand and Foot System?

CanMINI Hand and Foot System is a medical device that received FDA 510(k) clearance on 2025-04-24. It is manufactured by Canwell Medical Co., Ltd.. The 510(k) number is K242973.

When was CanMINI Hand and Foot System approved by the FDA?

CanMINI Hand and Foot System received FDA 510(k) clearance on 2025-04-24, under approval number K242973.

What company makes CanMINI Hand and Foot System?

CanMINI Hand and Foot System is manufactured by Canwell Medical Co., Ltd..

What is the FDA product code for CanMINI Hand and Foot System?

The FDA product code for CanMINI Hand and Foot System is HRS.

Other Devices by Canwell Medical Co., Ltd.

K161151Spinal fixation system

Related Devices (Code: HRS)

K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc. K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc. K162974Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation K163007Biomet Microfixation SternaLock 360 Sternal Closure SystemBiomet Microfixation K161696aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5Aap Implantate AG K161747LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5Aap Implantate AG

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.