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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 K253990
Device Name KHEIRON® Spinal Fixation System, including patient specific K-ROD
Applicant
S.M.A.I.O
2 Place Berthe Morisot
Saint Priest,  FR 69800
Applicant Contact Jean-Charles Roussouly
Correspondent
BioVera, Inc.
65 Promenade Saint Louis
Notrre-Dame-De-L'Ile-Perrot,  CA J7W3J6
Correspondent Contact Robert A. Poggie
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Code
KWP  
Date Received12/12/2025
Decision Date 01/07/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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