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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Retractor
510(k) Number K151104
Device Name OTELO LL
Applicant
Spineart
International Center Cointrin
20 Rte. De Pre-Bois Cp1813
Geneva,  CH 1215
Applicant Contact Franck Pennesi
Correspondent
Spineart
International Center Cointrin
20 Rte. De Pre-Bois Cp1813
Geneva,  CH 1215
Correspondent Contact Franck Pennesi
Regulation Number878.4800
Classification Product Code
GAD  
Date Received04/24/2015
Decision Date 01/06/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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