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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 K161859
Device Name MagnetOs
Applicant
XPAND BIOTECHNOLOGY BV
PROFESSOR BRONKHORSTLAAN 10D, BUILDING 48
BILTHOVEN,  NL 3723 MB
Applicant Contact YVONNE P. BOVELL
Correspondent
XPAND BIOTECHNOLOGY BV
PROFESSOR BRONKHORSTLAAN 10D, BUILDING 48
BILTHOVEN,  NL 3723 MB
Correspondent Contact YVONNE P. BOVELL
Regulation Number888.3045
Classification Product Code
MQV  
Date Received07/06/2016
Decision Date 02/24/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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