FDA 510(k)

Ventana C Spinal System

K-Number: K222833 · 2023-05-19

Decision Date2023-05-19

Product CodeODP

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Ventana C Spinal System is a medical device manufactured by Spinal Elements, Inc.. It received FDA 510(k) clearance on 2023-05-19 under approval number K222833. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ventana C Spinal System?

Ventana C Spinal System is a medical device that received FDA 510(k) clearance on 2023-05-19. It is manufactured by Spinal Elements, Inc.. The 510(k) number is K222833.

When was Ventana C Spinal System approved by the FDA?

Ventana C Spinal System received FDA 510(k) clearance on 2023-05-19, under approval number K222833.

What company makes Ventana C Spinal System?

Ventana C Spinal System is manufactured by Spinal Elements, Inc..

What is the FDA product code for Ventana C Spinal System?

The FDA product code for Ventana C Spinal System is ODP.

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Related PubMed Literature

PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by Spinal Elements, Inc.

K153352Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical Interbody System K160465Spinal Elements' Spinous Process Plate System K152011Lucent Intervertebral Body Fusion Device K170235Lucent® K182584Lucent® XP K181837Spinal Elements Ti-Bond coated devices

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Related Devices (Code: ODP)

K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd. K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.