510(k) clearance
KHEIRON® Spinal Fixation System, including patient specific K-ROD
- 510(k) number
- K262828
- Applicant
- S.M.A.I.O
- Decision date
- Sep 4, 2026
- Date received
- Aug 10, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Product code
- NKB
- Device type
- Thoracolumbosacral Pedicle Screw System
- Device class
- Class II
- Regulation
- 21 CFR 888.3070
- Advisory committee
- Orthopedic
- Statement or summary
- Summary
- Third party
- N
- Location
- Saint-Priest, FR