FDA 510(k) Application Details - K233315

Device Classification Name	More FDA Info for this Device
510(K) Number	K233315
Device Name	HipXpert and HipInsight System
Applicant	Surgical Planning Associates, Inc New England Baptist Hospital 125 Parker Hill Ave Suite 545 Boston, MA 02120 US Other 510(k) Applications for this Company
Contact	Stephen Murphy Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OSF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/2023
Decision Date	08/08/2024
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