Class Class II
MASADA Modular Spinal Fixation System (K243259)
Description
MASADA Modular Spinal Fixation System by Astura Medical, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243259
Clearance Date2025-01-07
Clearance TypeTraditional
Product CodeNKB
Regulation Number888.3070
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243259
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. MASADA Modular Spinal Fixation System (K243259) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231694 | MASADA Modular Spinal Fixation System | Astura Medical | 2023 |
| K182239 | OLYMPIC Posterior Spinal Fixation System | Astura Medical, LLC | 2018 |
| K172166 | OLYMPIC Navigated Instruments | Astura Medical | 2018 |
| K124058 | CREO STABILIZATION SYSTEM | Globus Medical, Inc. | 2013 |
Trace the full predicate network for K243259
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.