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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 S.A.
5389 Route De Strasbourg - Vancia
Rillieux-La-Pape,  FR 69140
Applicant Contact David Ryan
Correspondent
Medicrea International S.A.
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
Recalls CDRH Recalls
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