CYLOX ST 12° CY12101614

GUDID 04047844123911

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 ID04047844123911
NIH Device Record Keydd041001-2ba0-467c-acdc-12178aa456d9
Commercial Distribution StatusIn Commercial Distribution
Brand NameCYLOX ST 12°
Version Model NumberCervical cage, angled
Catalog NumberCY12101614
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
GS104047844123911 [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 12°]

04047844124086The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844124000The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123997The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123980The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123973The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123966The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123959The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123942The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123935The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123928The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123911The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123904The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123898The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123881The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123874The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123867The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123850The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123843The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123836The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123829The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123812The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123805The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123799The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123782The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844123775The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system
04047844122853The 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.