KHEIRON® Spinal Fixation System, including patient specific K-ROD
S.M.A.I.O · Orthopedic
Open FDA's page for this record- Third party flag
- N
- City
- Saint-Priest
- Advisory committee description
- Orthopedic
- Address 1
- 2, Pl. Berthe Morisot
- Statement or summary
- Summary
- Product code
- NKB
- Zip code
- 69800
- Applicant
- S.M.A.I.O
- Decision date
- 2026-09-04
- Decision code
- SESE
- Country code
- FR
- Device name
- KHEIRON® Spinal Fixation System, including patient specific K-ROD
- Advisory committee
- OR
- Contact
- Jean-Charles Roussouly
- K number
- K262828
- Date received
- 2026-08-10
- Review advisory committee
- OR
- Postal code
- 69800
- Decision description
- Substantially Equivalent
- Clearance type
- Special
- Harmonized identifiers (openFDA)
- Device name
- Thoracolumbosacral Pedicle Screw System
- Medical specialty description
- Orthopedic
- Regulation number
- 888.3070
- Device class
- 2
- Registration number
- 1000493591, 3009380063, 3007922509, 9617544, 2029275, 1000432246, 9611274, 3010057495, 3012447612, 2648623, 1835831, 3015443158, 3004635447, 3010123256, 3004638600, 3008285983, 1528646, 3031261833, 2032098, 3009998573, 3003387384, 3040335671, 3010866843, 1424434, 3004049923, 8020776, 3005819474, 9611827, 3006493760, 3043543260, 3009540749, 3006404071, 3011656326, 3009417901, 3015179588, 1056553, 3011795235, 3023138345, 3007345964, 3022159082 +375 more
- FEI number
- 1000493591, 3009380063, 3001551180, 3007922509, 1000116116, 1000432246, 3010057495, 3012447612, 2648623, 3015443158, 3004635447, 3010123256, 3004638600, 3008285983, 3002807113, 3031261833, 1000136451, 3009998573, 3003387384, 3040335671, 3010866843, 3003110073, 3004049923, 3005819474, 1000115656, 3003112432, 3006493760, 3043543260, 3000215273, 3009540749, 3006404071, 3011656326, 3009417901, 3015179588, 3011795235, 5870, 3023138345, 3007345964, 3022159082, 3010440433 +375 more