CYLOX ST 8° CY08041512

GUDID 04047844123454

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.

SIGNUS Medizintechnik GmbH

Metallic spinal interbody fusion cage
Primary Device ID04047844123454
NIH Device Record Key953c62f9-af8c-4399-a133-94673f8582cd
Commercial Distribution StatusIn Commercial Distribution
Brand NameCYLOX ST 8°
Version Model NumberCervical cage, angled
Catalog NumberCY08041512
Company DUNS344203948
Company NameSIGNUS Medizintechnik GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com

Device Dimensions

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Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104047844123454 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVEIntervertebral Fusion Device With Integrated Fixation, Cervical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-09
Device Publish Date2025-09-01

On-Brand Devices [CYLOX ST 8°]

04047844123683The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123676The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123669The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123652The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123645The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123638The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123621The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123614The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123607The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123591The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123584The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123577The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123560The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123553The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123546The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123539The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123522The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123515The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123508The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123492The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123485The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123478The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123461The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123454The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844122778The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844122761The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844122754The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844122747The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844122730The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844122723The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844122716The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844122709The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844122693The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844122686The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844122679The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844122662The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844122655The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844122648The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844122631The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844122624The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844122617The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844122600The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844122594The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844122587The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844122570The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
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