FDA 510(k) Application Details - K230078

Device Classification Name	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer   More FDA Info for this Device
510(K) Number	K230078
Device Name	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Applicant	Amplitude 11, Cours Jacques Offenbach-ZA Mozard 2 Valence 26000 FR Other 510(k) Applications for this Company
Contact	Hugo Catois Other 510(k) Applications for this Contact
Regulation Number	888.3560   More FDA Info for this Regulation Number
Classification Product Code	JWH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/10/2023
Decision Date	11/03/2023
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