Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

VERTICALE® Cervical System

K-Number: K192013 · 2020-04-07

ApplicantSilony Medical GmbH
Decision Date2020-04-07
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VERTICALE® Cervical System is a medical device manufactured by Silony Medical GmbH. It received FDA 510(k) clearance on 2020-04-07 under approval number K192013. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERTICALE® Cervical System?

VERTICALE® Cervical System is a medical device that received FDA 510(k) clearance on 2020-04-07. It is manufactured by Silony Medical GmbH. The 510(k) number is K192013.

When was VERTICALE® Cervical System approved by the FDA?

VERTICALE® Cervical System received FDA 510(k) clearance on 2020-04-07, under approval number K192013.

What company makes VERTICALE® Cervical System?

VERTICALE® Cervical System is manufactured by Silony Medical GmbH.

What is the FDA product code for VERTICALE® Cervical System?

The FDA product code for VERTICALE® Cervical System is NKG.

Related Clinical Trials

NCT07606196 The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases COMPLETED NCT05489822 PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use. TERMINATED NCT07153536 Spinal Cord Stimulation Combined With Physical Therapy in Post-Stroke Upper-Limb Motor Hemiparesis RECRUITING NCT05305430 Real World Data Collection on the Synergy Cervical Disc RECRUITING NCT05880823 Post Market Data Collection Protocol to Evaluate the Performance of the Synergy Disc WITHDRAWN NCT06383962 Post-Market Data Collection to Evaluate the Performance of the Synergy Disc® RECRUITING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

View all 12 devices →

Related Devices (Code: NKG)

K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG K162300Reform® POCT SystemPrecision Spine, Inc. K162136CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc. K161478Xenco Medical Posterior Cervical SystemXenco Medical, LLC K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, 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.

↑