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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spinal Pedicle Fixation
510(k) Number K111127
Device Name ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
Applicant
Spineart
Cointrin 20 Rte. De Pre-Bois
Cp1813
Geneva,  CH 1215
Applicant Contact FRANCK PENNESI
Correspondent
Spineart
Cointrin 20 Rte. De Pre-Bois
Cp1813
Geneva,  CH 1215
Correspondent Contact FRANCK PENNESI
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   MNH  
Date Received04/21/2011
Decision Date 08/11/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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