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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Fixation Cerclage, Sublaminar
510(k) Number K171881
Device Name JAZZ Passer Band
Applicant
Implanet, S.A.
Technopole Bordeaux Montesquieu, Allee Francois Magendie
Martillac,  FR 33650
Applicant Contact Fabienne Larquey Cadiere
Correspondent
Hogan Lovells US LLP
1835 Market St., 29th Floor
Philedelphia,  PA  19103
Correspondent Contact Janice M. Hogan
Regulation Number888.3010
Classification Product Code
OWI  
Date Received06/23/2017
Decision Date 08/08/2017
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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