FDA 510(k) Application Details - K210556

Device Classification Name	More FDA Info for this Device
510(K) Number	K210556
Device Name	Preview Shoulder
Applicant	Genesis Software Innovations 220 Lyon St NW Suite 500 Grand Rapids, MI 49503 US Other 510(k) Applications for this Company
Contact	Matt Miller 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	02/25/2021
Decision Date	04/21/2021
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