FDA.reportPublic FDA data

Stable-L Interbody System

Primary DI
B6785254720
Brand
Stable-L Interbody System
Company
NEXUS SPINE, L.L.C.
Model
525472
Device description
STABLE-L BLADE BASED INTERBODY 41X31X18, 6 DEG
Published
2025-08-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243934000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243934000Stable-L Lumbar Interbody SystemNexus Spine, LLC2025-04-30OVD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B6785254720PrimaryHIBCC0

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
Depth31Millimeter
Height18Millimeter
Width41Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
028137605
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B6785221380Tranquil-L™5221382021-12-17
B6785221390Tranquil-L™5221392021-12-17
B6785221400Tranquil-L™5221402021-12-17
B6785221410Tranquil-L™5221412021-12-17
B6785221420Tranquil-L™5221422021-12-17
B6785221430Tranquil-L™5221432021-12-17
B6785221440Tranquil-L™5221442021-12-17
B6785221450Tranquil-L™5221452021-12-17
B6785221460Tranquil-L™5221462021-12-17
B6785221470Tranquil-L™5221472021-12-17
B6785221480Tranquil-L™5221482021-12-17
B6785221490Tranquil-L™5221492021-12-17
B6785221500Tranquil-L™5221502021-12-17
B6785221510Tranquil-L™5221512021-12-17
B6785221520Tranquil-L™5221522021-12-17
B6785221530Tranquil-L™5221532021-12-17
B6785221540Tranquil-L™5221542021-12-17
B6785221550Tranquil-L™5221552021-12-17
B6785221560Tranquil-L™5221562021-12-17
B6785221570Tranquil-L™5221572021-12-17

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10889981231279RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981214395MeridianSeaspine Orthopedics CorporationOVD2020-12-30
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