Cleared Traditional

Tesera-K SC System

K223105 · Kyocera Medical Technologies, Inc. · Orthopedic

Dec 2022

Decision

83d

Days

Class 2

Risk

About This 510(k) Submission

K223105 is an FDA 510(k) clearance for the Tesera-K SC System, a Intervertebral Fusion Device With Integrated Fixation, Cervical (Class II — Special Controls, product code OVE), submitted by Kyocera Medical Technologies, Inc. (Redlands, US). The FDA issued a Cleared decision on December 22, 2022, 83 days after receiving the submission on September 30, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K223105 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 2022
Decision Date	December 22, 2022
Days to Decision	83 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

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