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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K260786
Device Name KHEIRON® Spinal Fixation System, including patient specific K-ROD
Applicant
S.M.A.I.O
2 Pl. Berthe Morisot
Saint-Priest,  FR 69800
Applicant Contact Jean-Charles ROUSSOULY
Correspondent
BioVera, Inc.
65 Promenade Saint Louis
Notre-Dame-De-L’Ile-Perrot,  CA J7W3J6
Correspondent Contact Robert A. Poggie
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Code
KWP  
Date Received03/10/2026
Decision Date 04/03/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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