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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Growing Rod System
510(k) Number K191212
Device Name CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System, EXPEDIUM SFX Cross Connectors, EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, E-Z Link Cross Connectors, ISOLA Spine System, MONARCH Spine System, MOSS MIAMI Spine System, TiMX Low Back System, VIPER Fenestrated Screw System, VIPER PRIME System, VIPER PRIME Fenestrated Screws, VIPER SAI (Sacral-Alar-Iliac), VIPER System, VIPER 2 System, VSP Spine System
Applicant
Medos International SARL
Chemin-Blanc 38
Lelocle,  CH 2400
Applicant Contact Sergio M. Cordeiro
Correspondent
Depuy Synthes Spine
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact Sergio M. Cordeiro
Regulation Number888.3070
Classification Product Code
PGM  
Subsequent Product Codes
JDN   JDQ   KWP   KWQ   NKB  
Date Received05/06/2019
Decision Date 09/24/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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