K241517
- 510(k) number
- K241517
- Device name
- Q Guidance System; Mako Spine System;
- Applicant
- Stryker Leibinger GmbH & Co KG DE
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2024-08-27
- Date received
- 2024-05-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K241517.pdf
Official FDA record: K241517
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.