K243419
- 510(k) number
- K243419
- Device name
- Altus Spine Navigation System
- Applicant
- Altus Partners, LLC PA · US
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2025-05-08
- Date received
- 2024-11-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 3.6 MB · U.S. public domain
Also available from FDA: K243419.pdf
Official FDA record: K243419
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.