FDA 510(k) Application Details - K250921

Device Classification Name	More FDA Info for this Device
510(K) Number	K250921
Device Name	CORIOGRAPH Pre-Op Planning and Modeling Services
Applicant	Blue Belt Technologies, Inc. 2875 Railroad Street Pittsburgh, PA 15090 US Other 510(k) Applications for this Company
Contact	Corrine Herlinger Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PBF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/27/2025
Decision Date	06/25/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review