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FDA 510(k)

VERTICALE® Triangular Fixation System

K-Number: K223806 · 2023-07-06

ApplicantSilony Medical GmbH
Decision Date2023-07-06
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VERTICALE® Triangular Fixation System is a medical device manufactured by Silony Medical GmbH. It received FDA 510(k) clearance on 2023-07-06 under approval number K223806. 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® Triangular Fixation System?

VERTICALE® Triangular Fixation System is a medical device that received FDA 510(k) clearance on 2023-07-06. It is manufactured by Silony Medical GmbH. The 510(k) number is K223806.

When was VERTICALE® Triangular Fixation System approved by the FDA?

VERTICALE® Triangular Fixation System received FDA 510(k) clearance on 2023-07-06, under approval number K223806.

What company makes VERTICALE® Triangular Fixation System?

VERTICALE® Triangular Fixation System is manufactured by Silony Medical GmbH.

What is the FDA product code for VERTICALE® Triangular Fixation System?

The FDA product code for VERTICALE® Triangular Fixation System is NKB.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT05489822 PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use. TERMINATED NCT07245719 Stryker Universal Midface and Upper-Face Fixation System: A Retrospective Post Market Follow Up COMPLETED NCT07485829 Zimmer Biomet-RibFix Titan RECRUITING

Other Devices by Silony Medical GmbH

K171434ROCCIA® MultiLIF K162587ROCCIA® ACIF K181899ROCCIA® PLIF K180963ROCCIA ALIF, ROCCIA TLIF K171421VERTICALE® Posterior Spinal Fixation System/VERTICALE® System K190680FAVO S-TLIF

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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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