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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 K190376
Device Name PASS LP Spinal System
Applicant
Medicrea International SA
5389 Route De Strasbourg - Vancia
Rillieux-La-Pape,  FR 69140
Applicant Contact David Ryan
Correspondent
Medicrea International SA
5389 Route De Strasbourg - Vancia
Rillieux-La-Pape,  FR 69140
Correspondent Contact David Ryan
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Code
KWP  
Date Received02/19/2019
Decision Date 05/02/2019
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
Recalls CDRH Recalls
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