K241171
- 510(k) number
- K241171
- Device name
- 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
- Applicant
- Stryker Leibinger GmbH & Co KG DE
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2024-07-25
- Date received
- 2024-04-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K241171.pdf
Official FDA record: K241171
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.