FDA.reportPublic FDA data

CoreLink 3D Lateral Cage

Primary DI
M7253LL18453014
Brand
CoreLink 3D Lateral Cage
Company
CORELINK LLC
Model
3LL1845-3014
Device description
F3D Lateral 18mm x 45mm x 14mm x 30°
Published
2025-01-06
Public version status
Update
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
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
K231743000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231743000F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate SystemCorelink, LLC2023-12-08MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M7253LL18453014PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation plate, non-bioabsorbableA small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
6019191119info@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
00193982313524ELSAGLOBUS MEDICAL, INC.OVD2026-08-14
00193982313531ELSAGLOBUS MEDICAL, INC.OVD2026-08-14
00193982313548ELSAGLOBUS MEDICAL, INC.OVD2026-08-14
00193982313555ELSAGLOBUS MEDICAL, INC.OVD2026-08-14
00193982313562ELSAGLOBUS MEDICAL, INC.OVD2026-08-14
00841732168091MONDRIAN ALIF Cage with Supplementary Fixation PlateCTL Medical CorporationOVD2026-08-14
00841732168107MONDRIAN ALIF Cage with Supplementary Fixation PlateCTL Medical CorporationOVD2026-08-14
00841732168114MONDRIAN ALIF Cage with Supplementary Fixation PlateCTL Medical CorporationOVD2026-08-14
00841732168121MONDRIAN ALIF Cage with Supplementary Fixation PlateCTL Medical CorporationOVD2026-08-14
00841732168138MONDRIAN ALIF Cage with Supplementary Fixation PlateCTL Medical CorporationOVD2026-08-14
00889095311532INDEPENDENCE MISGLOBUS MEDICAL, INC.OVD2026-08-14
00889095311549INDEPENDENCE MISGLOBUS MEDICAL, INC.OVD2026-08-14
00889095311556INDEPENDENCE MISGLOBUS MEDICAL, INC.OVD2026-08-14
00889095311563INDEPENDENCE MISGLOBUS MEDICAL, INC.OVD2026-08-14
00889095311570INDEPENDENCE MISGLOBUS MEDICAL, INC.OVD2026-08-14
00889095311587INDEPENDENCE MISGLOBUS MEDICAL, INC.OVD2026-08-14
03700780640195Idys®-ALIF ZP 3DTiCLARIANCEOVD2026-07-28
03700780654611Idys®-ALIF ZP 3DTiCLARIANCEOVD2026-07-28
00643169511651SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511675MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511682MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511712MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511729MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511736MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511774MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511781MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511798MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511804MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511811MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511828MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19