Cleared Traditional

Ventana? L Spinal System

K231252 · Spinal Elements, Inc. · Orthopedic

Jun 2023

Decision

60d

Days

Class 2

Risk

About This 510(k) Submission

K231252 is an FDA 510(k) clearance for the Ventana? L Spinal System, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by Spinal Elements, Inc. (Carlsbad, US). The FDA issued a Cleared decision on June 30, 2023, 60 days after receiving the submission on May 1, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K231252 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 01, 2023
Decision Date	June 30, 2023
Days to Decision	60 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3080
Definition	Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.