Class Class II
iFuse TORQ TNT™ Implant System (K241504)
Description
iFuse TORQ TNT™ Implant System by SI-BONE, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241504
Clearance Date2024-08-19
Clearance TypeTraditional
Product CodeOUR
Regulation Number888.3040
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241504
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. iFuse TORQ TNT™ Implant System (K241504) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K203247 | iFuse-TORQ Implant System | SI-BONE, Inc. | 2021 |
| K161616 | DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthe... | Synthes USA Products, LLC | 2017 |
Trace the full predicate network for K241504
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.