Cleared Traditional

E3D?-A Interbody System

K232432 · Evolution Spine · Orthopedic

Jan 2024

Decision

172d

Days

Class 2

Risk

About This 510(k) Submission

K232432 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 January 30, 2024, 172 days after receiving the submission on August 11, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K232432 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 11, 2023
Decision Date	January 30, 2024
Days to Decision	172 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.