Cleared Traditional

Lucent? XP

K182584 · Spinal Elements, Inc. · Orthopedic

Dec 2018

Decision

81d

Days

Class 2

Risk

About This 510(k) Submission

K182584 is an FDA 510(k) clearance for the Lucent? XP, 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 December 10, 2018, 81 days after receiving the submission on September 20, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K182584 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 20, 2018
Decision Date	December 10, 2018
Days to Decision	81 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.