CYLOX ST 0° CY00091614

GUDID 04047844123263

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 ID04047844123263
NIH Device Record Key269ce262-cfa9-4315-ba99-e2e0c71f3b9c
Commercial Distribution StatusIn Commercial Distribution
Brand NameCYLOX ST 0°
Version Model NumberCervical cage, straight
Catalog NumberCY00091614
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

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

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
GS104047844123263 [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 0°]

04047844123362The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123355The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123348The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123331The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123324The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123317The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123300The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123294The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123287The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123270The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123263The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123256The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123249The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123232The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123225The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123218The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123201The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123195The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123188The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123171The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123164The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123157The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123140The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123133The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844122495The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844122488The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844122471The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844122464The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844122457The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844122440The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844122433The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844122426The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844122419The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844122402The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844122396The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844122389The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844122372The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844122365The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844122358The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844122341The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844122334The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844122327The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844122310The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844122303The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844122297The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.