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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 K253577
Device Name IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)
Applicant
Medicrea International S.A.S. (Medtronic)
5389 Route De Strasbourg - Vancia
Rillieux-La-Pape,  FR 69140
Applicant Contact Gautier Liegeon
Correspondent
Medicrea International S.A.S. (Medtronic)
5389 Route De Strasbourg - Vancia
Rillieux-La-Pape,  FR 69140
Correspondent Contact Gautier Liegeon
Regulation Number888.3080
Classification Product Code
MAX  
Date Received11/17/2025
Decision Date 12/19/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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