Cleared Traditional

Ventana? A Anterior Lumbar Interbody System

K253559 · Spinal Elements, Inc. · Orthopedic

Feb 2026

Decision

100d

Days

Class 2

Risk

About This 510(k) Submission

K253559 is an FDA 510(k) clearance for the Ventana? A Anterior Lumbar Interbody System, a Intervertebral Fusion Device With Integrated Fixation, Lumbar (Class II — Special Controls, product code OVD), submitted by Spinal Elements, Inc. (Carlsbad, US). The FDA issued a Cleared decision on February 25, 2026, 100 days after receiving the submission on November 17, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K253559 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 17, 2025
Decision Date	February 25, 2026
Days to Decision	100 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.