FDA.reportPublic FDA data

CoreLink 3D Lateral Cage

Primary DI
M7253LL18452016
Brand
CoreLink 3D Lateral Cage
Company
CORELINK LLC
Model
3LL1845-2016
Device description
F3D Lateral 18mm x 45mm x 16mm x 20°
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
M7253LL18452016PrimaryHIBCC0

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
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10889981230937RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230944RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230951RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230968RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230975RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230982RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230999RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981231002RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981231019RegattaSeaspine Orthopedics CorporationOVD2021-02-02
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10889981231255RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981231262RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981231279RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981214395MeridianSeaspine Orthopedics CorporationOVD2020-12-30
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10889981214418MeridianSeaspine Orthopedics CorporationOVD2020-12-30
10889981214425MeridianSeaspine Orthopedics CorporationOVD2020-12-30
10889981214432MeridianSeaspine Orthopedics CorporationOVD2020-12-30
10889981214449MeridianSeaspine Orthopedics CorporationOVD2020-12-30
10889981214456MeridianSeaspine Orthopedics CorporationOVD2020-12-30
10889981214463MeridianSeaspine Orthopedics CorporationOVD2020-12-30
10889981214470MeridianSeaspine Orthopedics CorporationOVD2020-12-30
10889981214487MeridianSeaspine Orthopedics CorporationOVD2020-12-30
10889981214616MeridianSeaspine Orthopedics CorporationOVD2020-12-30