FDA 510(k) Application Details - K172833

Device Classification Name	Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented   More FDA Info for this Device
510(K) Number	K172833
Device Name	Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, 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	OQI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/19/2017
Decision Date	06/12/2018
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