The French company's KHEIRON posterior fixation system was cleared including the K-ROD, a rod contoured to the individual patient's surgical plan.
- Type
- FDA decision
- Company
- S.M.A.I.O
- Device
- KHEIRON Spinal Fixation System with patient-specific K-ROD
- Date
- 4 September 2026
- Jurisdiction
- US
- Classification
- 510(k) K262828 (NKB; KWP)
- Source
- FDA 510(k) database
Official source →Source checked