FDA.reportPublic FDA data

CoreLink Foundation 3D ALIF Stand-Alone Screw

Primary DI
M7251025515
Brand
CoreLink Foundation 3D ALIF Stand-Alone Screw
Company
CORELINK LLC
Model
10255-15
Device description
Foundation 3D Stand Alone Screw-ALIF, Variable Self Drilling, 5.5mm x 15mm
Published
2024-08-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M7251025515PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
601-919-1119info@zavation.com

Regulatory Flags#

DUNS number
064191453
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M7253LL22603020CoreLink Foundation 3D Lateral Cage3LL2260-30202025-01-06
M7253LL18350008CoreLink 3D Lateral Cage3LL1835-00082025-01-06
M7253LL18350010CoreLink 3D Lateral Cage3LL1835-00102025-01-06
M7253LL18350012CoreLink 3D Lateral Cage3LL1835-00122025-01-06
M7253LL18350808CoreLink 3D Lateral Cage3LL1835-08082025-01-06
M7253LL18350810CoreLink 3D Lateral Cage3LL1835-08102025-01-06
M7253LL18350812CoreLink 3D Lateral Cage3LL1835-08122025-01-06
M7253LL18400008CoreLink 3D Lateral Cage3LL1840-00082025-01-06
M7253LL18400010CoreLink 3D Lateral Cage3LL1840-00102025-01-06
M7253LL18400012CoreLink 3D Lateral Cage3LL1840-00122025-01-06
M7253LL18400808CoreLink 3D Lateral Cage3LL1840-08082025-01-06
M7253LL18400810CoreLink 3D Lateral Cage3LL1840-08102025-01-06
M7253LL18400812CoreLink 3D Lateral Cage3LL1840-08122025-01-06
M7253LL18450008CoreLink 3D Lateral Cage3LL1845-00082025-01-06
M7253LL18450010CoreLink 3D Lateral Cage3LL1845-00102025-01-06
M7253LL18450012CoreLink 3D Lateral Cage3LL1845-00122025-01-06
M7253LL18450014CoreLink 3D Lateral Cage3LL1845-00142025-01-06
M7253LL18450808CoreLink Foundation 3D Lateral Cage3LL1845-08082025-01-06
M7253LL18450810CoreLink Foundation 3D Lateral Cage3LL1845-08102025-01-06
M7253LL18450812CoreLink Foundation 3D Lateral Cage3LL1845-08122025-01-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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