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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 K254017
Device Name SWINGO-3D Lumbar Cage System
Applicant
Implanet
Technopole Bordeaux Montesquieu
Allee Francois Magendie,  FR 33650
Applicant Contact Regis Le Couedic
Correspondent
MRC Global, LLC
9160 Hwy. 64, Suite 12
P.O. Box 330
Lakeland,  TN  38002
Correspondent Contact Jen McBride
Regulation Number888.3080
Classification Product Code
MAX  
Date Received12/15/2025
Decision Date 02/26/2026
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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