Class Class II
Signature Osteosynthesis Plate System (K241599)
Description
Signature Osteosynthesis Plate System by Signature Orthopaedic Pty , Ltd., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241599
Clearance Date2025-02-06
Clearance TypeTraditional
Product CodeHRS
Regulation Number888.3030
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241599
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. Signature Osteosynthesis Plate System (K241599) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K171320 | ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS /... | Meril Healthcare Pvt. , Ltd. | 2018 |
Trace the full predicate network for K241599
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.