FDA.reportPublic FDA data

CoreLink LATERAL PLATE

Primary DI
M72590011516
Brand
CoreLink LATERAL PLATE
Company
CORELINK LLC
Model
900115-16
Device description
LATERAL PLATE, ONE HOLE 16MM, 1 SCREW, UP, 15MM X 16MM
Published
2025-01-03
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
KWQAppliance, Fixation, Spinal Intervertebral Body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190016000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190016000Lateral Plate SystemCorelink, LLC2019-06-12KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M72590011516PrimaryHIBCC0

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
Moist Heat or Steam 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
00840466901035PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901042PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901059PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901066PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901073PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901080PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901097PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901103PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901110PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901127PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901141PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901158PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901165PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901172PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901479PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901486PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901493PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901509PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901516PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901523PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901530PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901547PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901554PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901561PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901578PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901585PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901592PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901608PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901615PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901622PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21