TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System (K240061)
Description
TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System by Smith & Nephew, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240061
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. TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System (K240061) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K061019 | TRIGEN META-NAIL RETROGRADE FEMORAL AND TIBIAL NAILS | Smith & Nephew, Inc. | 2006 |
| K040212 | TRIGEN INTERTAN | Smith & Nephew, Inc. | 2004 |
Trace the full predicate network for K240061
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.