K231479
- 510(k) number
- K231479
- Device name
- TriALTIS Spine System
- Applicant
- Medos International SARL CH
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2023-09-22
- Date received
- 2023-05-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K231479.pdf
Official FDA record: K231479
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.