K233684
- 510(k) number
- K233684
- Device name
- TriALTIS Spine System
- Applicant
- Medos International SARL CH
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2023-12-12
- Date received
- 2023-11-16
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K233684.pdf
Official FDA record: K233684
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.