Cleared Traditional

Lucent XP, Lucent XP Curved

K202298 · Spinal Elements, Inc. · Orthopedic

Dec 2020

Decision

131d

Days

Class 2

Risk

About This 510(k) Submission

K202298 is an FDA 510(k) clearance for the Lucent XP, Lucent XP Curved, 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 22, 2020, 131 days after receiving the submission on August 13, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K202298 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 13, 2020
Decision Date	December 22, 2020
Days to Decision	131 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.