Cleared Special

PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System

K230808 · Kyocera Medical Technologies, Inc. · Orthopedic

Apr 2023

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K230808 is an FDA 510(k) clearance for the PEEK 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 April 21, 2023, 29 days after receiving the submission on March 23, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K230808 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 23, 2023
Decision Date	April 21, 2023
Days to Decision	29 days
Submission Type	Special
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.