FDA 510(k) Application Details - K242272

Device Classification Name	More FDA Info for this Device
510(K) Number	K242272
Device Name	CORIOGRAPH Pre-Op Planning and Modeling Services
Applicant	Blue Belt Technologies, Inc. 2875 Railroad Street Pittsburgh, PA 15222 US Other 510(k) Applications for this Company
Contact	Chandler Caufield Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/01/2024
Decision Date	11/15/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review