FDA 510(k) Application Details - DEN220033

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN220033
Device Name	MISHA Knee System
Applicant	Moximed, Inc. 46602 Landing Parkway Fremont, CA 94538 US Other 510(k) Applications for this Company
Contact	Nancy E. Issac Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QVV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/06/2022
Decision Date	04/10/2023
Decision	DENG -
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review