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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 Bone Graft, Lumbar
510(k) Number K181899
Device Name ROCCIA® PLIF
Applicant
Silony Medical GmbH
Leinfelder Strasse 60
Leinfelden-Echterdingen,  DE 70771
Applicant Contact Bircan Tasdelen
Correspondent
Silony Medical GmbH
Leinfelder Strasse 60
Leinfelden-Echterdingen,  DE 70771
Correspondent Contact Bircan Tasdelen
Regulation Number888.3080
Classification Product Code
MAX  
Date Received07/16/2018
Decision Date 12/13/2018
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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