Cleared Traditional

E3D?-C Interbody System

K241846 · Evolution Spine · Orthopedic

Aug 2024

Decision

47d

Days

Class 2

Risk

About This 510(k) Submission

K241846 is an FDA 510(k) clearance for the E3D?-C Interbody System, a Intervertebral Fusion Device With Integrated Fixation, Cervical (Class II — Special Controls, product code OVE), submitted by Evolution Spine (Dallas, US). The FDA issued a Cleared decision on August 12, 2024, 47 days after receiving the submission on June 26, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K241846 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 26, 2024
Decision Date	August 12, 2024
Days to Decision	47 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

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