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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 K173782
Device Name UNiD Patient Specific 3D printed cage
Applicant
Medicrea International SA
5389 Rte. De Strasbourg - Vancia
Rillieux-La-Pape,  FR 69140
Applicant Contact David Ryan
Correspondent
Medicrea International SA
5389 Rte. De Strasbourg - Vancia
Rillieux-La-Pape,  FR 69140
Correspondent Contact David Ryan
Regulation Number888.3080
Classification Product Code
MAX  
Date Received12/13/2017
Decision Date 04/25/2018
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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