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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 K213111
Device Name MagnetOs granules
Applicant
Kuros Biosciences B.V
Professor Bronkhorstlaan 10, Bldg. 48
Bilthoven,  NL 3723 MB
Applicant Contact Sonja van der Meer
Correspondent
MCRA, LLC
1050 K. St. NW
Suite 1000
Washington,  DC  20001
Correspondent Contact Mehdi Kazemzadeh-Narbat
Regulation Number888.3045
Classification Product Code
MQV  
Date Received09/24/2021
Decision Date 01/10/2022
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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