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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K252437
Device Name JAZZ Spinal System
Applicant
Implanet
Technopole Bordeaux Montesquieu
Allee Francois Magendie,  FR 33650
Applicant Contact Regis Le Couedic
Correspondent
MRC Global, LLC
9085 E. Mineral Cir., Suite 110
Centennial,,  CO  80112
Correspondent Contact Christine Scifert
Regulation Number888.3070
Classification Product Code
NKB  
Date Received08/01/2025
Decision Date 08/28/2025
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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