FDA.reportPublic FDA data

FOUNDATION System

Primary DI
M725XA1321
Brand
FOUNDATION System
Company
CORELINK LLC
Model
XA1321
Catalog number
XA1321
Device description
FOUNDATION XL ANT LUMBAR CAGE - 21MM X 28MM X 41MM - 13 DEGREE
Published
2016-01-21
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
MAXIntervertebral fusion device with bone graft, lumbar
ODPIntervertebral fusion device with bone graft, cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M725XA1321PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric 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 non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] 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
Angle13degree
Height21Millimeter
Length41Millimeter
Width28Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(314)863-5401customer.service@corelinksurgical.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

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