VERTICALE® Cervical System
Posterior Cervical Screw System
Silony Medical GmbH
The following data is part of a premarket notification filed by Silony Medical Gmbh with the FDA for Verticale® Cervical System.
Pre-market Notification Details
| Device ID | K192013 |
| 510k Number | K192013 |
| Device Name: | VERTICALE® Cervical System |
| Classification | Posterior Cervical Screw System |
| Applicant | Silony Medical GmbH Leinfelder StraBe 60 Leinfelden-echterdingen, DE 70771 |
| Contact | Melanie Lubjuhn |
| Correspondent | Melanie Lubjuhn Silony Medical GmbH Leinfelder StraBe 60 Leinfelden-echterdingen, DE 70771 |
| Product Code | NKG |
| CFR Regulation Number | 888.3075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-29 |
| Decision Date | 2020-04-07 |
Trademark Results [VERTICALE]
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 |
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