FDA 510(k) Application Details - K222106

Device Classification Name	More FDA Info for this Device
510(K) Number	K222106
Device Name	Waypoint GPS
Applicant	Waypoint Orthopedics, Inc. 300 Applebrooke Drive Malvern, PA 19355 US Other 510(k) Applications for this Company
Contact	Tiffini Wittwer Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QWP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/18/2022
Decision Date	05/12/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review