Cleared Traditional

Ventana? C Spinal System

K222833 · Spinal Elements, Inc. · Orthopedic

May 2023

Decision

241d

Days

Class 2

Risk

About This 510(k) Submission

K222833 is an FDA 510(k) clearance for the Ventana? C Spinal System, a Intervertebral Fusion Device With Bone Graft, Cervical (Class II — Special Controls, product code ODP), submitted by Spinal Elements, Inc. (Carlsbad, US). The FDA issued a Cleared decision on May 19, 2023, 241 days after receiving the submission on September 20, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K222833 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 20, 2022
Decision Date	May 19, 2023
Days to Decision	241 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	ODP — Intervertebral Fusion Device With Bone Graft, 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.