Cleared Traditional

KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System

K193320 · Kyocera Medical Technologies, Inc. · Orthopedic

Feb 2020

Decision

64d

Days

Class 2

Risk

About This 510(k) Submission

K193320 is an FDA 510(k) clearance for the KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System, a Intervertebral Fusion Device With Integrated Fixation, Lumbar (Class II — Special Controls, product code OVD), submitted by Kyocera Medical Technologies, Inc. (Redlands, US). The FDA issued a Cleared decision on February 4, 2020, 64 days after receiving the submission on December 2, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K193320 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 02, 2019
Decision Date	February 04, 2020
Days to Decision	64 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OVD — Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3080
Definition	Intended To Stabilize Lumbar Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation.