Cleared Traditional

Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System, Ceres-C Spinal System, Omega XP Spinal System

K210044 · Spinal Elements, Inc. · Orthopedic

Jun 2021

Decision

174d

Days

Class 2

Risk

About This 510(k) Submission

K210044 is an FDA 510(k) clearance for the Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System, Ceres-C Spinal System, Omega XP 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 June 30, 2021, 174 days after receiving the submission on January 7, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K210044 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 07, 2021
Decision Date	June 30, 2021
Days to Decision	174 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.