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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 K240392
Device Name JAZZ Spinal System
Applicant
Implanet
Technopole Bordeaux Montesquieu
Allee F. Magendie,  FR 33650
Applicant Contact Regis Le Couedic
Correspondent
MRC Global
9085 E. Mineral Circle,
Suite 110
Centennial,  CO  80112
Correspondent Contact Christine Scifert
Regulation Number888.3070
Classification Product Code
NKB  
Date Received02/08/2024
Decision Date 05/06/2024
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
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