FDA 510(k) Application Details - K232842

Device Classification Name	Cement, Bone, Vertebroplasty   More FDA Info for this Device
510(K) Number	K232842
Device Name	Cement, Bone, Vertebroplasty
Applicant	Ningbo HicRen Biotechnology Co., Ltd. Building 1 Block B No.777 Binhai 4th Road Hangzhou Bay New District Ningbo 315336 CN Other 510(k) Applications for this Company
Contact	Qian Jia Other 510(k) Applications for this Contact
Regulation Number	888.3027   More FDA Info for this Regulation Number
Classification Product Code	NDN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/14/2023
Decision Date	02/29/2024
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