Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q Footswitch; PI Drive 2 Motors; Elite Q Attachments and Cutting Accessories (K241171)
Description
Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q Footswitch; PI Drive 2 Motors; Elite Q Attachments and Cutting Accessories by Stryker Leibinger GmbH & Co KG, an FDA 510(k) cleared neurology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241171
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. Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q Footswitch; PI Drive 2 Motors; Elite Q Attachments and Cutting Accessories (K241171) cites 0 predicate devices and is itself cited by 2 later devices.
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243958 | Consolidated Operating Room Equipment (CORE) 2 Console | Stryker Instruments | 2025 |
| K241517 | Q Guidance System; Mako Spine System; | Stryker Leibinger GmbH & Co KG | 2024 |
Trace the full predicate network for K241171
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.