FDA 510(k) Application Details - K212156

Device Classification Name	Filler, Bone Void, Calcium Compound   More FDA Info for this Device
510(K) Number	K212156
Device Name	Filler, Bone Void, Calcium Compound
Applicant	ACRO Biomedical Co., Ltd. 3rd Fl., No.57, Luke 2nd Rd., Lujhu Dist. Kaohsiung 82151 TW Other 510(k) Applications for this Company
Contact	Dar-Jen Hsieh 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	07/12/2021
Decision Date	10/08/2021
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