FDA 510(k) Application Details - K163441

Device Classification Name	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented   More FDA Info for this Device
510(K) Number	K163441
Device Name	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Applicant	UNITED ORTHOPEDIC CORPORATION NO 57, PARK AVE 2, SCIENCE PARK HSINCHU 300 TW Other 510(k) Applications for this Company
Contact	GIMPEL CHIEN Other 510(k) Applications for this Contact
Regulation Number	888.3353   More FDA Info for this Regulation Number
Classification Product Code	LZO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/08/2016
Decision Date	08/25/2017
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