K243514
- 510(k) number
- K243514
- Device name
- Salvo® Robotic Navigation Instruments
- Applicant
- Spine Wave, Inc. CT · US
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2025-04-03
- Date received
- 2024-11-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K243514.pdf
Official FDA record: K243514
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.