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FDA 510(k) Application Details - K202639
Device Classification Name
Filler, Bone Void, Calcium Compound
More FDA Info for this Device
510(K) Number
K202639
Device Name
Filler, Bone Void, Calcium Compound
Applicant
Biostone Ltd
BioCity, Pennyfoot Street
Nottingham NG1 1GF GB
Other 510(k) Applications for this Company
Contact
Wei-Jen Lo
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
09/11/2020
Decision Date
04/21/2021
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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