FDA 510(k) Application Details - K234008

Device Classification Name	More FDA Info for this Device
510(K) Number	K234008
Device Name	CERAMENT G
Applicant	BoneSupport AB Scheelevagen 19 Ideon Science Park SE-223 70 Lund 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	12/19/2023
Decision Date	03/13/2024
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