FDA 510(k) Application Details - K191803

Device Classification Name	Pin, Fixation, Threaded   More FDA Info for this Device
510(K) Number	K191803
Device Name	Pin, Fixation, Threaded
Applicant	Tinavi (Anhui) Medical Technologies Co., Ltd. Building 5,Robot Industrial Base of TusCity, Jinxiu Avenue/Susong Road, Hefei 230601 CN Other 510(k) Applications for this Company
Contact	Jianhua Jiang Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	JDW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/03/2019
Decision Date	04/14/2020
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