Cleared Traditional

Lucent 3D Spinal System

K203254 · Spinal Elements, Inc. · Orthopedic

Mar 2021

Decision

142d

Days

Class 2

Risk

About This 510(k) Submission

K203254 is an FDA 510(k) clearance for the Lucent 3D Spinal System, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by Spinal Elements, Inc. (Carlsbad, US). The FDA issued a Cleared decision on March 26, 2021, 142 days after receiving the submission on November 4, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K203254 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 04, 2020
Decision Date	March 26, 2021
Days to Decision	142 days
Submission Type	Traditional
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.