Cleared Traditional

VERTICALE? Cervical System

K192013 · Silony Medical GmbH · Orthopedic

Apr 2020

Decision

253d

Days

Class 2

Risk

About This 510(k) Submission

K192013 is an FDA 510(k) clearance for the VERTICALE? Cervical System, a Posterior Cervical Screw System (Class II — Special Controls, product code NKG), submitted by Silony Medical GmbH (Leinfelden-Echterdingen, DE). The FDA issued a Cleared decision on April 7, 2020, 253 days after receiving the submission on July 29, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3075.

Submission Details

510(k) Number	K192013 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 29, 2019
Decision Date	April 07, 2020
Days to Decision	253 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	NKG — Posterior Cervical Screw System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3075
Definition	Posterior Cervical Screw Systems Are Intended For Use In Fusion Procedures Of The Cervical Spine And/or Craniocervical Junction And/or Cervicothoracic Junction For: 1) Spinal Fractures And Dislocations; 2) Deformities; 3) Instabilities; 4) Failed Previous Fusions; 5) Tumors; 6) Inflammatory Disorders; 7) Spinal Degeneration, 8) Facet Degeneration With Instability; And 9) Reconstruction Following Decompression To Treat Radiculopathy And/or Myelopathy. These Systems Are Also Intended To Stabilize The Spine In The Absence Of Fusion For A Limited Time Period In Patients With Tumors Involving The Cervical Spine In Whom Life Expectancy Is Of Insufficient Duration To Permit Achievement Of Fusion.