Class Class II
Q Guidance System; Mako Spine System; (K241517)
Description
Q Guidance System; Mako Spine System; by Stryker Leibinger GmbH & Co KG, an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241517
Clearance Date2024-08-27
Clearance TypeTraditional
Product CodeOLO
Regulation Number882.4560
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241517
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. Q Guidance System; Mako Spine System; (K241517) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241171 | Spine Guidance Software (Version 5.1); Consolidated Operati... | Stryker Leibinger GmbH & Co KG | 2024 |
| K241011 | Mako Total Knee Application | Mako Surgical Corp. | 2024 |
Trace the full predicate network for K241517
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.