FDA 510(k) Application Details - DEN210044

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN210044
Device Name	CERAMENT G
Applicant	BoneSupport AB Scheelevagen 19, Ideon Science Park Lund SE 223-70 SE Other 510(k) Applications for this Company
Contact	Blerta Shuka Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QRR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/28/2021
Decision Date	05/17/2022
Decision	DENG -
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review