Cleared Special

E3D?-C Interbody System

K260038 · Evolution Spine · Orthopedic

Feb 2026

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K260038 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 February 4, 2026, 29 days after receiving the submission on January 6, 2026. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K260038 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 06, 2026
Decision Date	February 04, 2026
Days to Decision	29 days
Submission Type	Special
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.