K231527
- 510(k) number
- K231527
- Device name
- TriALTIS Navigation Enabled Instruments
- Applicant
- Medos International Sàrl CH
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2023-09-29
- Date received
- 2023-05-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K231527.pdf
Official FDA record: K231527
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.