FDA 510(k) Application Details - K201347

Device Classification Name	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive   More FDA Info for this Device
510(K) Number	K201347
Device Name	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
Applicant	DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, IN 46582 US Other 510(k) Applications for this Company
Contact	Karen Mahoney Other 510(k) Applications for this Contact
Regulation Number	888.3560   More FDA Info for this Regulation Number
Classification Product Code	OIY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/21/2020
Decision Date	06/18/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review