Cleared Special

KMTI S141 Lumbar Interbody Fusion System

K212070 · Kyocera Medical Technologies, Inc. · Orthopedic

Aug 2021

Decision

59d

Days

Class 2

Risk

About This 510(k) Submission

K212070 is an FDA 510(k) clearance for the KMTI S141 Lumbar Interbody Fusion System, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by Kyocera Medical Technologies, Inc. (Redlands, US). The FDA issued a Cleared decision on August 30, 2021, 59 days after receiving the submission on July 2, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K212070 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 02, 2021
Decision Date	August 30, 2021
Days to Decision	59 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3080
Definition	Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.