K253249
- 510(k) number
- K253249
- Device name
- TriALTIS Spine System
- Applicant
- Medos International SARL CH
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2025-10-21
- Date received
- 2025-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K253249.pdf
Official FDA record: K253249
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.