Cleared Traditional

Lucent Intervertebral Body Fusion Device

K152011 · Spinal Elements, Inc. · Orthopedic

Jun 2016

Decision

324d

Days

Class 2

Risk

About This 510(k) Submission

K152011 is an FDA 510(k) clearance for the Lucent Intervertebral Body Fusion Device, 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 June 9, 2016, 324 days after receiving the submission on July 21, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K152011 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 21, 2015
Decision Date	June 09, 2016
Days to Decision	324 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.