Class Class II
EGPS Navigated Instruments (K240160)
Description
EGPS Navigated Instruments by Astura Medical, an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240160
Clearance Date2024-10-17
Clearance TypeTraditional
Product CodeOLO
Regulation Number882.4560
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240160
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. EGPS Navigated Instruments (K240160) cites 3 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 |
| K171651 | EXCELSIUS GPS | Globus Medical, Inc. | 2017 |
Trace the full predicate network for K240160
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.