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FDA 510(k) Application Details - K202458
Device Classification Name
Bone Cement
More FDA Info for this Device
510(K) Number
K202458
Device Name
Bone Cement
Applicant
Osartis GmbH
Auf der Beune 101
Munster 64839 DE
Other 510(k) Applications for this Company
Contact
Volker Stirnal
Other 510(k) Applications for this Contact
Regulation Number
888.3027
More FDA Info for this Regulation Number
Classification Product Code
LOD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/27/2020
Decision Date
05/18/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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