K253990
- 510(k) number
- K253990
- Device name
- KHEIRON® Spinal Fixation System, including patient specific K-ROD
- Applicant
- S.M.A.I.O FR
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2026-01-07
- Date received
- 2025-12-12
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K253990.pdf
Official FDA record: K253990
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.