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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 K201659
Device Name KHEIRON® Spinal Fixation System
Applicant
S.M.A.I.O
2, Place Berthe Morisot – Parc Technologique
Saint-Priest,  FR 69800
Applicant Contact Stephanie Escoffier
Correspondent
The OrthoMedix Group, Inc.
4313 W. 3800 S.
West Heven,  UT  84401
Correspondent Contact J.D. Webb
Regulation Number888.3070
Classification Product Code
NKB  
Date Received06/18/2020
Decision Date 10/05/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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