Class Class II
Tibia and Fibula System (K213059)
Description
Tibia and Fibula System by Auxein Medical Private Limited, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK213059
Clearance Date2023-01-27
Clearance TypeTraditional
Product CodeHRS
Regulation Number888.3030
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K213059
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. Tibia and Fibula System (K213059) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K141680 | AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand ... | Auxein Medical | 2015 |
| K073460 | SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES | Synthes (Usa) | 2008 |
| K020602 | SYNTHES PILON PLATE | Synthes | 2002 |
Trace the full predicate network for K213059
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.