FDA 510(k) Application Details - K230045

Device Classification Name	More FDA Info for this Device
510(K) Number	K230045
Device Name	HipCheck
Applicant	Stryker Corp. 5900 Optical Ct San Jose, CA 95138 US Other 510(k) Applications for this Company
Contact	Lucas Dun Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/06/2023
Decision Date	09/29/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review