FDA 510(k) Application Details - K162237

Device Classification Name	Intraoperative Orthopedic Joint Assessment Aid   More FDA Info for this Device
510(K) Number	K162237
Device Name	Intraoperative Orthopedic Joint Assessment Aid
Applicant	XPANDORTHO, INC. 2223 AVENIDA DE LA PLAYA SUITE 203 LA JOLLA, CA 92037-3218 US Other 510(k) Applications for this Company
Contact	REBECCA K PINE 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	08/09/2016
Decision Date	04/25/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review