Cleared Traditional

EVOLUTION SPINE Interbody System

K223146 · Evolution Spine · Orthopedic

Feb 2023

Decision

125d

Days

Class 2

Risk

About This 510(k) Submission

K223146 is an FDA 510(k) clearance for the EVOLUTION SPINE Interbody System, a Intervertebral Fusion Device With Integrated Fixation, Lumbar (Class II — Special Controls, product code OVD), submitted by Evolution Spine (Dallas, US). The FDA issued a Cleared decision on February 7, 2023, 125 days after receiving the submission on October 5, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K223146 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 05, 2022
Decision Date	February 07, 2023
Days to Decision	125 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OVD — Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3080
Definition	Intended To Stabilize Lumbar Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation.