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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 the device name listed in this FDA 510(k) record. The listed applicant is Silony Medical GmbH. It received FDA 510(k) clearance on 2020-04-07 under 510(k) 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. The listed applicant is Silony Medical GmbH. The 510(k) number is K192013.

When did VERTICALE® Cervical System receive FDA 510(k) clearance?

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

Who is the listed applicant for VERTICALE® Cervical System?

The FDA 510(k) record lists Silony Medical GmbH as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05489822PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use.TERMINATED

Other records listing Silony Medical GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253921VERTICALE® Navigation InstrumentsK254148VERTICALE GPS InstrumentsK223806VERTICALE® Triangular Fixation SystemK223649VERTICALE® Navigation InstrumentsK212007VERTICALE Navigation InstrumentsK190680FAVO S-TLIF

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Related Devices (Code: NKG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw SystemCarboFix Orthopedics , Ltd.K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AGK253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.K251725ANAX™ OCT Spinal SystemCg Medtech Co., Ltd.

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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