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

Contact Domains#

Product Codes#

Code, Name table
CodeName
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVEIntervertebral Fusion Device With Integrated Fixation, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243188000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243188000CYLOX® STSignus Medizintechnik GmbH2025-02-11OVE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04047844124819PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04047844124819040478441248194047844124819

GMDN Terms#

Term, Definition table
TermDefinition
Metallic spinal interbody fusion cageA 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
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49602391660info@signus.com

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 DIBrandModelCatalogPublished
04047844005668KAINOS+Bone graft substitute, granules 2-3mmK001NT2015-09-24
04047844005675KAINOS+Bone graft substitute, granules 2-3mmK003NT2015-09-24
04047844005682KAINOS+Bone graft substitute, granules 2-3mmK004NT2015-09-24
04047844005699KAINOS+Bone graft substitute, granules 2-3mmK005NT2015-09-24
04047844005705KAINOS+Bone graft substitute, granules 2-3mmK006NT2015-09-24
04047844005712KAINOS+Bone graft substitute, insert for NUBICKNB0413142018-09-20
04047844005729KAINOS+Bone graft substitute, insert for NUBICKNB0513142018-09-20
04047844005736KAINOS+Bone graft substitute, insert for NUBICKNB0613142018-09-20
04047844005743KAINOS+Bone graft substitute, insert for NUBICKNB0713142018-09-20
04047844005750KAINOS+Bone graft substitute, insert for NUBICKNB0813142018-09-20
04047844005996KAINOS+Bone graft substitute, granules 1-2mmKS03NT2015-09-24
04047844006009KAINOS+Bone graft substitute, granules 1-2mmKS06NT2015-09-24
04047844023747KAINOS+Bone graft substitute, granulate 2-3mmK002NT2015-09-24
04047844130971DIPLOMATGuide wire, round/roundAC01622026-08-14
04047844130988DIPLOMATGuide wire, trocar/roundAC01632026-08-14
04047844066768DIPLOMATGuide wire, trocar/roundAC01262025-05-21
04047844042779DIPLOMATGuide wire obturatorAC0003-22022-06-09
04047844066751DIPLOMATGuide wire, round/roundAC01252022-06-09
04047844129418DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-951202026-07-13
04047844129425DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-450252026-07-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810216329235ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329242ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329259ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329266ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329273ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329280ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329297ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329303ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329310ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329334ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329341ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329358ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329372ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329389ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329396ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329402ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329419ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00889981124390Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981124406Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981124413Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981124420Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981124437Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981124444Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981124451Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981124468Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981142301Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981142318Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981142325Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981142332Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981142349Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26