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FDA 510(k) Application Details - K191274
Device Classification Name
Filler, Bone Void, Calcium Compound
More FDA Info for this Device
510(K) Number
K191274
Device Name
Filler, Bone Void, Calcium Compound
Applicant
BonAlive Biomaterials Ltd.
Biolinja 12
Turku 20750 FI
Other 510(k) Applications for this Company
Contact
Jimmy Lucchesi
Other 510(k) Applications for this Contact
Regulation Number
888.3045
More FDA Info for this Regulation Number
Classification Product Code
MQV
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/13/2019
Decision Date
08/07/2019
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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