FDA 510(k) Application Details - K240172

Device Classification Name	More FDA Info for this Device
510(K) Number	K240172
Device Name	Preview Shoulder
Applicant	Genesis Software Innovations 2851 Charlevoix Dr. SE Suite 327 Grand Rapids, MI 49546 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	01/22/2024
Decision Date	04/04/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review