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.
Device ID | K171421 |
510k Number | K171421 |
Device Name: | VERTICALE® Posterior Spinal Fixation System/VERTICALE® System |
Classification | Thoracolumbosacral Pedicle Screw System |
Applicant | Silony Medical GmbH Leinfelder StraBe 60 Leinfelden-echterdingen, DE 70771 |
Contact | Bircan Yilmaz |
Correspondent | Indraj Bamrah Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746 |
Product Code | NKB |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-05-15 |
Decision Date | 2018-01-10 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
VERTICALE 79166430 5015070 Live/Registered |
Silony Medical International AG 2015-02-13 |
VERTICALE 78349539 not registered Dead/Abandoned |
FORSYTH OF CANADA, INC. 2004-01-08 |
VERTICALE 78314201 3791547 Dead/Cancelled |
FORSYTH OF CANADA, INC. 2003-10-15 |