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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name orthosis, spondylolisthesis spinal fixation
510(k) Number K151695
Device Name Romeo posterior osteosynthesis system
Applicant
SPINEART
INTERNATIONAL CENTER COINTRIN
20 ROUTE DE PRE-BOIS, CP1813
Geneva,  CH 1215
Applicant Contact FRANCK PENNESI
Correspondent
SPINEART
INTERNATIONAL CENTER COINTRIN
20 ROUTE DE PRE-BOIS, CP1813
Geneva 15,  CH 1215
Correspondent Contact FRANCK PENNESI
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Code
MNI  
Date Received06/23/2015
Decision Date 09/10/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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