FDA 510(k) Application Details - K240453

Device Classification Name	Filler, Bone Void, Calcium Compound   More FDA Info for this Device
510(K) Number	K240453
Device Name	Filler, Bone Void, Calcium Compound
Applicant	OrthoRebirth Co., Ltd. 3-17-43 Chigasaki Higashi Yokohama 224-0033 JP Other 510(k) Applications for this Company
Contact	Yasutoshi Nishikawa 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	02/15/2024
Decision Date	03/04/2024
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