FDA 510(k) Application Details - K242928

Device Classification Name	More FDA Info for this Device
510(K) Number	K242928
Device Name	Tesera-k SC System
Applicant	Kyocera Medical Technologies, Inc. 1289 Bryn Mawr Avenue Redlands, CA 92374 US Other 510(k) Applications for this Company
Contact	Dennis Ty Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OVE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/24/2024
Decision Date	04/10/2025
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