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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 the device name listed in this FDA 510(k) record. The listed applicant is Silony Medical GmbH. It received FDA 510(k) clearance on 2018-01-10 under 510(k) 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. The listed applicant is Silony Medical GmbH. The 510(k) number is K171421.

When did VERTICALE® Posterior Spinal Fixation System/VERTICALE® System receive FDA 510(k) clearance?

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

Who is the listed applicant for VERTICALE® Posterior Spinal Fixation System/VERTICALE® 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® Posterior Spinal Fixation System/VERTICALE® System?

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

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.

NCT03118505A Study of Infuse® Bone Graft With Mastergraft® Strip and Posterior Fixation for Posterolateral Fusion (PLF) Treatment of Multi-Level Degenerative Lumbosacral Spinal ConditionsACTIVE_NOT_RECRUITING

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 InstrumentsK192013VERTICALE® Cervical System

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Related Devices (Code: NKB)

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.

K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.K253943Tiger 2 SystemZavation Medical Products, LLCK261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.OK253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak 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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