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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name posterior cervical screw system
510(k) Number K190895
Device Name MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT System, SUMMIT Fixation System
Applicant
Medos International Sarl
Chemin-Blanc 38
Le Locle,  CH 2400
Applicant Contact Sheree Geller
Correspondent
Depuy Synthes Spine
325 Paramount Drive
Raynham,  MA  02767
Correspondent Contact Sheree Geller
Regulation Number888.3075
Classification Product Code
NKG  
Subsequent Product Codes
HRS   HWC   KWP  
Date Received04/05/2019
Decision Date 07/18/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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