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FDA 510(k) Application Details - K231528
Device Classification Name
Filler, Bone Void, Calcium Compound
More FDA Info for this Device
510(K) Number
K231528
Device Name
Filler, Bone Void, Calcium Compound
Applicant
Bonalive Biomaterials, Ltd.
Biolinja 12
Turku 20750 FI
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Contact
Kristoffer Sibelius
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
05/26/2023
Decision Date
07/11/2023
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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