K252871
- 510(k) number
- K252871
- Device name
- Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories
- Applicant
- Stryker Leibinger GmbH & Co KG DE
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2026-02-06
- Date received
- 2025-09-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 1.7 MB · U.S. public domain
Also available from FDA: K252871.pdf
Official FDA record: K252871
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.