FDA.reportPublic FDA data

Stable-C™

Primary DI
B6785230140
Brand
Stable-C™
Company
NEXUS SPINE, L.L.C.
Model
523014
Device description
Cervical IBD 10x16x13, Planar, 6 Deg, Anchors
Published
2021-12-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
K181621000
K231763000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181621000Stable-C Interbody SystemNexus Spine, LLC2018-10-19OVE
K231763000Stable-C Interbody SystemNexus Spine, LLC2023-08-21OVE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B6785230140PrimaryHIBCC0

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 in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical 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 included with the device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height10Millimeter
Length13Millimeter
Width16Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
028137605
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B6785221580Tranquil-L™5221582021-12-17
B6785221590Tranquil-L™5221592021-12-17
B6785221600Tranquil-L™5221602021-12-17
B6785221610Tranquil-L™5221612021-12-17
B6785221620Tranquil-L™5221622021-12-17
B6785221630Tranquil-L™5221632021-12-17
B6785221640Tranquil-L™5221642021-12-17
B6785221650Tranquil-L™5221652021-12-17
B6785221660Tranquil-L™5221662021-12-17
B6785221670Tranquil-L™5221672021-12-17
B6785221680Tranquil-L™5221682021-12-17
B6785221690Tranquil-L™5221692021-12-17
B6785221700Tranquil-L™5221702021-12-17
B6785221710Tranquil-L™5221712021-12-17
B6785221720Tranquil-L™5221722021-12-17
B6785221730Tranquil-L™5221732021-12-17
B6785221740Tranquil-L™5221742021-12-17
B6785221750Tranquil-L™5221752021-12-17
B6785221760Tranquil-L™5221762021-12-17
B6785221770Tranquil-L™5221772021-12-17

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