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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Grafting Material, Synthetic
510(k) Number K201546
Device Name OsOpia Synthetic Bone Void Filler
Applicant
Revisios BV
Professor Bronkhorstlaan 10, Bldg. 48
3723 Mb Bilthoven,  NL
Applicant Contact Hen Baron
Correspondent
MRC Global
9085 E. Mineral Cir., Suite 110
Centennial,,  CO  80112
Correspondent Contact Kathy Remsen
Regulation Number872.3930
Classification Product Code
LYC  
Date Received06/09/2020
Decision Date 10/02/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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