Cleared Traditional

E3D?-A Interbody System

K240368 · Evolution Spine · Orthopedic

May 2024

Decision

99d

Days

Class 2

Risk

About This 510(k) Submission

K240368 is an FDA 510(k) clearance for the E3D?-A 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 May 15, 2024, 99 days after receiving the submission on February 6, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K240368 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 06, 2024
Decision Date	May 15, 2024
Days to Decision	99 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.