VERTICALE® Posterior Spinal Fixation System/VERTICALE® System

Thoracolumbosacral Pedicle Screw System

Silony Medical GmbH

The following data is part of a premarket notification filed by Silony Medical Gmbh with the FDA for Verticale® Posterior Spinal Fixation System/verticale® System.

Pre-market Notification Details

Device IDK171421
510k NumberK171421
Device Name:VERTICALE® Posterior Spinal Fixation System/VERTICALE® System
ClassificationThoracolumbosacral Pedicle Screw System
Applicant Silony Medical GmbH Leinfelder StraBe 60 Leinfelden-echterdingen,  DE 70771
ContactBircan Yilmaz
CorrespondentIndraj Bamrah
Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin,  TX  78746
Product CodeNKB  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-05-15
Decision Date2018-01-10
Summary:summary

Trademark Results [VERTICALE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VERTICALE
VERTICALE
79166430 5015070 Live/Registered
Silony Medical International AG
2015-02-13
VERTICALE
VERTICALE
78349539 not registered Dead/Abandoned
FORSYTH OF CANADA, INC.
2004-01-08
VERTICALE
VERTICALE
78314201 3791547 Dead/Cancelled
FORSYTH OF CANADA, INC.
2003-10-15
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