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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 K241164
Device Name IB3D™ PL Spinal System
Applicant
Medicrea International S.A.S. (Medtronic)
5389 Route De Strasbourg - Vancia
Rillieux-La-Pape,  FR 69140
Applicant Contact Cecile Humbert
Correspondent
Medicrea International S.A.S. (Medtronic)
5389 Route De Strasbourg - Vancia
Rillieux-La-Pape,  FR 69140
Correspondent Contact Cecile Humbert
Regulation Number888.3080
Classification Product Code
MAX  
Date Received04/26/2024
Decision Date 09/06/2024
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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