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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name intervertebral fusion device with bone graft, lumbar
510(k) Number K191134
Device Name IB3D ALIF
Medicrea International S.A.
5389, route de Strasbourg
rillieux-la-pape,  FR 69140
Applicant Contact david ryan
Medicrea International S.A.
5389 route de Strasbourg - Vancia
rillieux-la-pape,  FR 69140
Correspondent Contact david ryan
Regulation Number888.3080
Classification Product Code
Date Received04/29/2019
Decision Date 10/30/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No