Home GUDID 04047844124819 CYLOX ST
Primary DI 04047844124819
Brand CYLOX ST
Company SIGNUS Medizintechnik GmbH
Model Variable angle screw, self drilling, 2-thread
Catalog number CYVB2-4012
Device description The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system. Zhe system is comprised of interbodies, plates, and screws. The interbody device can be used as a stand alone implant with screw holes for integrated fixation, or as a construct fixed with a plate and screws. The interbody implants are additively manufactured from titanium alloy (Ti-6Al-4V ELI). The plates and screws are traditionally machined from titanium alloy (Ti-6Al-4V). The SIGNUS CYLOX® ST Interbody System is placed in the C3 – T1 spinal region via the Cloward or Smith-Robinson approach. The interbody is available in four different footprints, with multiple heights and angulations. The standalone interbody contains a central hole and two holes angulated for fixation with screws into the cranial and caudal vertebral body. The construct interbody contains a central hole and indentation features to mate with the anterior plate. The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
Published 2025-09-11
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true
Product Codes# Code, Name table Code Name OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 04047844124819 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04047844124819 04047844124819 4047844124819
GMDN Terms# Term, Definition table Term Definition Metallic spinal interbody fusion cage A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is typically in the form of a hollow, porous, threaded and/or fenestrated cylindrical, or disc-shaped device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be packaged with the cage.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 0 Degrees Celsius 35 Degrees Celsius
Regulatory Flags# DUNS number 344203948 Device count 1 Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 04047844130971 DIPLOMAT Guide wire, round/round AC0162 2026-08-14 04047844130988 DIPLOMAT Guide wire, trocar/round AC0163 2026-08-14 04047844066768 DIPLOMAT Guide wire, trocar/round AC0126 2025-05-21 04047844042779 DIPLOMAT Guide wire obturator AC0003-2 2022-06-09 04047844066751 DIPLOMAT Guide wire, round/round AC0125 2022-06-09 04047844129418 DIPLOMAT FT Pedicle screw w/o tulip, cannulated, polyaxial AB0222-95120 2026-07-13 04047844129425 DIPLOMAT FT Pedicle screw w/o tulip, cannulated, polyaxial AB0222-45025 2026-07-13 04047844129432 DIPLOMAT FT Pedicle screw w/o tulip, cannulated, polyaxial AB0222-45030 2026-07-13 04047844129449 DIPLOMAT FT Pedicle screw w/o tulip, cannulated, polyaxial AB0222-45035 2026-07-13 04047844129456 DIPLOMAT FT Pedicle screw w/o tulip, cannulated, polyaxial AB0222-45040 2026-07-13 04047844129463 DIPLOMAT FT Pedicle screw w/o tulip, cannulated, polyaxial AB0222-45045 2026-07-13 04047844129470 DIPLOMAT FT Pedicle screw w/o tulip, cannulated, polyaxial AB0222-45050 2026-07-13 04047844129487 DIPLOMAT FT Pedicle screw w/o tulip, cannulated, polyaxial AB0222-45055 2026-07-13 04047844129494 DIPLOMAT FT Pedicle screw w/o tulip, cannulated, polyaxial AB0222-45060 2026-07-13 04047844129500 DIPLOMAT FT Pedicle screw w/o tulip, cannulated, polyaxial AB0222-55025 2026-07-13 04047844129517 DIPLOMAT FT Pedicle screw w/o tulip, cannulated, polyaxial AB0222-55030 2026-07-13 04047844129524 DIPLOMAT FT Pedicle screw w/o tulip, cannulated, polyaxial AB0222-55035 2026-07-13 04047844129531 DIPLOMAT FT Pedicle screw w/o tulip, cannulated, polyaxial AB0222-55040 2026-07-13 04047844129548 DIPLOMAT FT Pedicle screw w/o tulip, cannulated, polyaxial AB0222-55045 2026-07-13 04047844129555 DIPLOMAT FT Pedicle screw w/o tulip, cannulated, polyaxial AB0222-55050 2026-07-13
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00810216325442 ZSAlign Cervical Interbody System-Spacer-Wedge Zsfab, Inc. OVE 2026-08-17 00810216325466 ZSAlign Cervical Interbody System-Spacer-Wedge Zsfab, Inc. OVE 2026-08-17 00810216325800 ZSAlign Cervical Interbody System-Spacer-Wedge Zsfab, Inc. OVE 2026-08-17 00810216325817 ZSAlign Cervical Interbody System-Spacer-Wedge Zsfab, Inc. OVE 2026-08-17 00810216325824 ZSAlign Cervical Interbody System-Spacer-Wedge Zsfab, Inc. OVE 2026-08-17 00810216325831 ZSAlign Cervical Interbody System-Spacer-Wedge Zsfab, Inc. OVE 2026-08-17 00810216325848 ZSAlign Cervical Interbody System-Spacer-Wedge Zsfab, Inc. OVE 2026-08-17 00810216325855 ZSAlign Cervical Interbody System-Spacer-Wedge Zsfab, Inc. OVE 2026-08-17 00810216325862 ZSAlign Cervical Interbody System-Spacer-Wedge Zsfab, Inc. OVE 2026-08-17 00810216325879 ZSAlign Cervical Interbody System-Spacer-Wedge Zsfab, Inc. OVE 2026-08-17 00810216325886 ZSAlign Cervical Interbody System-Spacer-Wedge Zsfab, Inc. OVE 2026-08-17 00810216325893 ZSAlign Cervical Interbody System-Spacer-Wedge Zsfab, Inc. OVE 2026-08-17 00810216325909 ZSAlign Cervical Interbody System-Spacer-Wedge Zsfab, Inc. OVE 2026-08-17 00810216325916 ZSAlign Cervical Interbody System-Spacer-Wedge Zsfab, Inc. OVE 2026-08-17 00810216325923 ZSAlign Cervical Interbody System-Spacer-Wedge Zsfab, Inc. OVE 2026-08-17 00810216325930 ZSAlign Cervical Interbody System-Spacer-Wedge Zsfab, Inc. OVE 2026-08-17 00810216325947 ZSAlign Cervical Interbody System-Spacer-Wedge Zsfab, Inc. OVE 2026-08-17 00810216325954 ZSAlign Cervical Interbody System-Spacer-Wedge Zsfab, Inc. OVE 2026-08-17 00810216325961 ZSAlign Cervical Interbody System-Spacer-Wedge Zsfab, Inc. OVE 2026-08-17 00810216325978 ZSAlign Cervical Interbody System-Spacer-Wedge Zsfab, Inc. OVE 2026-08-17 00810216325985 ZSAlign Cervical Interbody System-Spacer-Wedge Zsfab, Inc. OVE 2026-08-17 00810216325992 ZSAlign Cervical Interbody System-Spacer-Wedge Zsfab, Inc. OVE 2026-08-17 00810216326005 ZSAlign Cervical Interbody System-Spacer-Wedge Zsfab, Inc. OVE 2026-08-17 00810216326012 ZSAlign Cervical Interbody System-Spacer-Wedge Zsfab, Inc. OVE 2026-08-17 00810216326029 ZSAlign Cervical Interbody System-Spacer-Wedge Zsfab, Inc. OVE 2026-08-17 00810216326036 ZSAlign Cervical Interbody System-Spacer-Wedge Zsfab, Inc. OVE 2026-08-17 00810216326043 ZSAlign Cervical Interbody System-Spacer-Wedge Zsfab, Inc. OVE 2026-08-17 00810216326050 ZSAlign Cervical Interbody System-Spacer-Wedge Zsfab, Inc. OVE 2026-08-17 00810216326067 ZSAlign Cervical Interbody System-Spacer-Wedge Zsfab, Inc. OVE 2026-08-17 00810216326074 ZSAlign Cervical Interbody System-Spacer-Wedge Zsfab, Inc. OVE 2026-08-17