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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 K231658
Device Name VEOS Spinal Fixation System
Applicant
Spineway
7 allée Moulin Berger
Ecully,  FR 69130
Applicant Contact Maurad Ben Mokhtar
Correspondent
The OrthoMedix Group, Inc.
4313 West 3800 South
West Haven,  UT  84401
Correspondent Contact J.D. Webb
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   OSH  
Date Received06/07/2023
Decision Date 10/10/2023
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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