FDA 510(k) Application Details - K193320

Device Classification Name	More FDA Info for this Device
510(K) Number	K193320
Device Name	KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System
Applicant	Kyocera Medical Technologies, Inc. 1200 California St, Suite 210 Redlands, CA 92374 US Other 510(k) Applications for this Company
Contact	Anthony DeBenedictis 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	12/02/2019
Decision Date	02/04/2020
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