FDA 510(k) Application Details - K220830

Device Classification Name	Intraoperative Orthopedic Joint Assessment Aid   More FDA Info for this Device
510(K) Number	K220830
Device Name	Intraoperative Orthopedic Joint Assessment Aid
Applicant	These Three Medical, LLC 20860 N. Tatum Blvd., Suite 300 Phoenix, AZ 85050 US Other 510(k) Applications for this Company
Contact	Moj Eram Other 510(k) Applications for this Contact
Regulation Number	882.4560   More FDA Info for this Regulation Number
Classification Product Code	ONN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/22/2022
Decision Date	09/15/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review