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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 integrated fixation, lumbar
510(k) Number K190877
Device Name Juliet® Ti LL Lumbar Interbody Device
Applicant
SPINEART
3 chemin du pre Fleuri
Plan Ouates,  CH 1228
Applicant Contact Franck Pennesi
Correspondent
SPINEART
3 chemin du pre Fleuri
Plan Ouates,  CH 1228
Correspondent Contact Franck Pennesi
Regulation Number888.3080
Classification Product Code
OVD  
Subsequent Product Code
MAX  
Date Received04/04/2019
Decision Date 05/29/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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