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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 K220374
Device Name EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)
Applicant
Medos International SARL
Chemin-Blanc 38
Lelocle,  CH 2400
Applicant Contact Megan Smith
Correspondent
Depuy Synthes Spine
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact Megan Smith
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ  
Date Received02/09/2022
Decision Date 03/08/2022
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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