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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 K213959
FOIA Releasable 510(k) K213959
Device Name MagnetOs Flex Matrix
Applicant
Kuros Biosciences B.V
Professor Bronkhorstlaan 10, Bldg. 48
Bilthoven,  NL 3723 MB
Applicant Contact Sonja van der Meer
Correspondent
Kuros Biosciences B.V
Professor Bronkhorstlaan 10, Bldg. 48
Bilthoven,  NL 3723 MB
Correspondent Contact Sonja van der Meer
Regulation Number888.3045
Classification Product Code
MQV  
Date Received12/17/2021
Decision Date 04/14/2022
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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