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FDA 510(k) Application Details - K192379
Device Classification Name
Bone Cement
More FDA Info for this Device
510(K) Number
K192379
Device Name
Bone Cement
Applicant
OSARTIS GmbH
Lagerstrasse 11-15
Dieburg 64807 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
08/30/2019
Decision Date
11/27/2019
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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