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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 K211201
Device Name MagnetOs Easypack Putty
Applicant
Kuros Biosciences B.V
Professor Bronkhorstlaan 10, Bldg. 48
Bilthoven,  NL 3723 MB
Applicant Contact Marcel Borger
Correspondent
Compliance Solutions, Ltd.
Suite 10, Dunswood House, 1 Dunswood Rd., Cumbernauld
Glasgow,  GB G67 3EN
Correspondent Contact Angela Paterson
Regulation Number888.3045
Classification Product Code
MQV  
Date Received04/22/2021
Decision Date 09/02/2021
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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