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FDA 510(k)

VERTICALE® Posterior Spinal Fixation System/VERTICALE® System

K-Number: K171421 · 2018-01-10

ApplicantSilony Medical GmbH
Decision Date2018-01-10
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VERTICALE® Posterior Spinal Fixation System/VERTICALE® System is a medical device manufactured by Silony Medical GmbH. It received FDA 510(k) clearance on 2018-01-10 under approval number K171421. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERTICALE® Posterior Spinal Fixation System/VERTICALE® System?

VERTICALE® Posterior Spinal Fixation System/VERTICALE® System is a medical device that received FDA 510(k) clearance on 2018-01-10. It is manufactured by Silony Medical GmbH. The 510(k) number is K171421.

When was VERTICALE® Posterior Spinal Fixation System/VERTICALE® System approved by the FDA?

VERTICALE® Posterior Spinal Fixation System/VERTICALE® System received FDA 510(k) clearance on 2018-01-10, under approval number K171421.

What company makes VERTICALE® Posterior Spinal Fixation System/VERTICALE® System?

VERTICALE® Posterior Spinal Fixation System/VERTICALE® System is manufactured by Silony Medical GmbH.

What is the FDA product code for VERTICALE® Posterior Spinal Fixation System/VERTICALE® System?

The FDA product code for VERTICALE® Posterior Spinal Fixation System/VERTICALE® System is NKB.

Related Clinical Trials

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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 Silony Medical GmbH

K171434ROCCIA® MultiLIF K162587ROCCIA® ACIF K181899ROCCIA® PLIF K180963ROCCIA ALIF, ROCCIA TLIF K190680FAVO S-TLIF K182608Oyster ACIF Cage

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Related Devices (Code: NKB)

K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC K162912VIPER PRIME™ additions to the VIPER® SystemMedos International SARL K162160Preference Elite Pedicle Screw SystemAmedica Corporation K162232MOSS 100 Pedicle Screw SystemBiedermann Motech GmbH & Co. KG K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.

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.

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