FDA 510(k) Application Details - K212980

Device Classification Name	More FDA Info for this Device
510(K) Number	K212980
Device Name	Tesera-k ALIF System
Applicant	Kyocera Medical Technologies, Inc. 1200 California Street, Ste. 210 Redlands, CA 92374 US Other 510(k) Applications for this Company
Contact	Scott Rucker Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OVD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/17/2021
Decision Date	01/07/2022
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