Class Class II
CanMINI Hand and Foot System (K242973)
Description
CanMINI Hand and Foot System by Canwell Medical Co., Ltd., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242973
Clearance Date2025-04-24
Clearance TypeAbbreviated
Product CodeHRS
Regulation Number888.3030
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242973
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. CanMINI Hand and Foot System (K242973) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K130108 | DOUBLE ENGINE BONE PLATE AND SCREW SYSTEMS | Xiamen Double Engine Medical Materi... | 2013 |
| K090047 | SYNTHES (USA) 1.5MM MINI FRAGMENT LCP SYSTEM | Synthes (Usa) | 2009 |
Trace the full predicate network for K242973
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.