FDA 510(k) Application Details - K201084

Device Classification Name	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer   More FDA Info for this Device
510(K) Number	K201084
Device Name	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Applicant	LimaCorporate S.p.A. Via Nazionale 52 Villanova di San Daniele del Friuli 33038 IT Other 510(k) Applications for this Company
Contact	Michela Zanotto Other 510(k) Applications for this Contact
Regulation Number	888.3565   More FDA Info for this Regulation Number
Classification Product Code	MBH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/23/2020
Decision Date	12/14/2020
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