K242042
- 510(k) number
- K242042
- Device name
- TriALTIS Spine System
- Applicant
- Medos International SARL CH
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2024-09-09
- Date received
- 2024-07-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K242042.pdf
Official FDA record: K242042
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.