FDA 510(k) Application Details - K190100

Device Classification Name	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer   More FDA Info for this Device
510(K) Number	K190100
Device Name	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Applicant	United Orthopedic Corporation No 57, Park Ave 2, Science Park Hsinchu 30075 TW Other 510(k) Applications for this Company
Contact	Lois Ho Other 510(k) Applications for this Contact
Regulation Number	888.3510   More FDA Info for this Regulation Number
Classification Product Code	KRO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/22/2019
Decision Date	09/23/2019
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