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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filler, Bone Void, Calcium Compound
510(k) Number K191274
Device Name BonAlive Granules
Applicant
Bonalive Biomaterials, Ltd.
Biolinja 12
Turku,  FI 20750
Applicant Contact Jimmy Lucchesi
Correspondent
Obelix Biotech Solutions
12416 Fairfax Ridge Place
Austin,  TX  78738
Correspondent Contact Elisa Maldonado-Holmertz
Regulation Number888.3045
Classification Product Code
MQV  
Date Received05/13/2019
Decision Date 08/07/2019
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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