VERTICALE Cervical System

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls found in the data synced 23 Oct 2026.

Trade Name

VERTICALE Cervical

Generic Name

General internal orthopaedic fixation system implantation kit

Bone tap, reusable

Device Name

Drill Guide (invasive)

Implant Modifier (non-invasive)

Handle

Control Gauges (invasive)

Tap

Implant Modifier (invasive)

Drill (powered)

Forceps and Clamps

Screw Driver (manual)

Awl

RePo Tool (invasive)

Trial

Drill Guide (non- invasive)

Apapter (non-invasive)

Model / Ref / Catalog

VI-0256.1, VI-0710, VI-0311, VI-0025, VI-0041, VI-0711, VI-0140, VI-0261, VI-0335, VI-0940, VI-0330, VI-0446, VI-0920, VI-0230.1, VI-0751, VI-0360.1, VI-0230.2, VI-0230, VI-0620, VI-0535, VI-0930.2, VI-0740, VI-0720.2, VI-0421, VI-0201, VI-0135, VI-0741, VI-0340, VI-0301, VI-0293, VI-0030.2, VI-0941, VI-0940.4, VI-0030.1, VI-0240, VI-0360.2, VI-0900, VI-0750, VI-0260, VI-0256, VI-0720, VI-0040, VI-0130.2, VI-0700, VI-0211, VI-0294

Primary DI / UDI-DI

04054896079776, 04054896079974, 04054896079813, 04054896079592, 04054896082370, 04054896079981, 04054896079684, 04054896082417, 04054896079837, 04054896106908, 04054896079820, 04054896079905, 04054896097794, 04054896079721, 04054896080079, 04054896081915, 04054896079738, 04054896079714, 04054896079943, 04054896079929, 04054896097817, 04054896080048, 04054896080017, 04054896079882, 04054896079691, 04054896079677, 04054896080055, 04054896079844, 04054896079806, 04054896106748, 04054896083254, 04054896131993, 04054896106786, 04054896083247, 04054896079752, 04054896081922, 04054896097763, 04054896080062, 04054896079790, 04054896079769, 04054896079998, 04054896079622, 04054896079653, 04054896079967, 04054896079707, 04054896106755

Basic UDI-DI

4054896DRILLGUIDEAZ, 4054896IMPLANTMODIEXAA, 4054896HANDLESW, 4054896CONTROLGAUGESEM, 4054896TAPFW, 4054896IMPLANTMODIISAC, 4054896DRILLMACHMF, 4054896FORCEPSCLAMPSISL6, 4054896SCREWDRIVERISJE, 4054896AWLER, 4054896REPOTOOLS3Q, 4054896TRIALS52, 4054896DRILLGUIDEAUX28, 4054896ADAPTERSV

510(k) Number

K192013 ↗

FDA Product Code

NKG 510(k)

OLO GUDID

EMDN Code

L091002, L091199, L098003, L091099, L091001, L091102

GMDN Term

General internal orthopaedic fixation system implantation kit

Bone tap, reusable

Device Class

Class I EUDAMED

Class IIa EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 888.3075 510(k)

882.4560 GUDID

EU market of registration

Germany

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

Sterilization Method

Moist Heat or Steam Sterilization

• ROCCIA MultiLIF, ALIF, TLIF

  Class IIa

  CE/MDR

• Verticale

  Class IIa

  CE/MDR

• Storage Elements

  Class I

  CE/MDR

• VERTICALE SI/Triangular Fixation

  Class I

  CE/MDR

• VERTICALE Cervical

  Class IIa

  CE/MDR

• Oyster ACIF

  Class IIa

  CE/MDR

See all devices from Silony Medical GmbH →

• What types of cervical spine conditions is the Verticale Cervical System designed to address in surgery?

  The Verticale Cervical System is specifically designed for surgical reconstruction or stabilization of the cervical spine, targeting degenerative conditions, trauma-related injuries, or deformities. It provides internal fixation to restore alignment and support where natural stability has been compromised.

• Is the Verticale Cervical System intended for reuse, or is it meant to be used only once?

  The Verticale Cervical System is explicitly labeled for single-use only, meaning each component—including screws, rods, and interbody cages—should be discarded after one surgical procedure to maintain sterility and safety.

• How should the Verticale Cervical System be stored to ensure it remains sterile before use?

  Since the system is supplied sterile, it must be stored and handled according to standard sterile medical device protocols. This includes keeping it in its original packaging, protected from contamination, and following manufacturer guidelines to preserve integrity until immediate preoperative use.

• What regulatory pathways does the Verticale Cervical System follow, and how does that affect its use?

  The device is cleared via FDA 510(k) under Traditional review (K192013) and complies with MDR (Medical Device Regulation) standards. This means it meets U.S. and EU requirements for safety and effectiveness, ensuring it can be legally used in surgeries where cervical spine stabilization is indicated, provided the surgeon adheres to approved surgical techniques.

• Are there different sizes or configurations available for the Verticale Cervical System, and why might that matter?

  Yes, the Verticale Cervical System includes sizes and configurations tailored for precise cervical spine applications, allowing surgeons to select components that match the patient’s anatomy and surgical needs. This customization ensures proper fit, stability, and alignment during reconstruction or fixation procedures.