K251804
- 510(k) number
- K251804
- 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
- 2025-07-08
- Date received
- 2025-06-12
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K251804.pdf
Official FDA record: K251804
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.