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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 K162764
Device Name JAZZ FRAME SYSTEM
Applicant
Implanet, S.A.
Technopole Bordeaux Montesquieu, Allee Francois Magendie
Martillac,  FR 33650
Applicant Contact REGIS LE COUEDIC
Correspondent
Hogan Lovells US LLP
1835 Market St., 29th Floor
Philedelphia,  PA  19103
Correspondent Contact JANICE M HOGAN
Regulation Number888.3070
Classification Product Code
NKB  
Date Received09/30/2016
Decision Date 01/19/2017
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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