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Ventana C Spinal System

by Spinal Elements, Inc.

510(k) K222833

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK222833 Date19 May 2023ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
ODP
Device class
Class II
Regulation
21 CFR Part 888.3080
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Ventana C Spinal System is a 3D-printed titanium interbody implant designed for spinal fusion procedures. It is classified as an Orthopedic Device (Product Code: ODP) and functions as an interbody cage to support and contain bone graft material within the cervical spine, facilitating structural stability and fusion.

This system is supplied as a single-use, sterile device intended for surgical use in spinal fusion procedures. It is manufactured using advanced 3D printing technology to enhance graft containment and radiographic visualization while minimizing titanium usage. The device is authorized under FDA 510(k) clearance (K222833) and is intended for use in orthopedic applications as defined by the Orthopedic (OR) Advisory Committee.

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Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of spinal procedures is the Ventana C Spinal System designed for, and how does its 3D-printed titanium construction benefit the patient?

    The Ventana C Spinal System is specifically designed for cervical spine fusion procedures, serving as an interbody cage to hold bone graft material and promote structural stability. Its 3D-printed titanium construction reduces material usage while improving graft containment and radiographic visibility, which helps surgeons monitor fusion progress more effectively during and after surgery.

  • Is the Ventana C Spinal System reusable, or is it intended for single-use only? How does this affect its sterility and handling?

    The Ventana C Spinal System is supplied as a single-use, sterile device, meaning each implant is intended for one surgical procedure only. This design ensures patient safety by eliminating cross-contamination risks and simplifies handling, as there’s no need for cleaning or reprocessing between uses.

  • What regulatory pathway was followed for FDA clearance of the Ventana C Spinal System, and which advisory committee was involved?

    The Ventana C Spinal System received FDA clearance through a Traditional 510(k) pathway, determined to be *substantially equivalent* to a predicate device. The review was conducted under the Orthopedic (OR) Advisory Committee, which evaluates spinal and orthopedic implants like this interbody cage for cervical fusion procedures.

  • How does the device’s design minimize titanium usage while maintaining structural integrity for spinal fusion?

    The Ventana C Spinal System leverages advanced 3D printing technology to create precise, lightweight titanium implants with optimized geometry. This reduces material waste compared to traditional manufacturing while preserving the necessary strength and stability required to support bone graft material and facilitate successful cervical spine fusion.