K253623
- 510(k) number
- K253623
- Device name
- Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update; Spine Guidance 5.4 Software Enable; Spine Guidance 5.4 Sales Demo; Q Drill Tracker; NavLock Adapter; Elite Q Attacments; Elite Cutting Accessories; Maestro Air Motor
- Applicant
- Stryker Leibinger GmbH & Co KG DE
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2026-02-19
- Date received
- 2025-11-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K253623.pdf
Official FDA record: K253623
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.