FDA.reportPublic FDA data

Advantage C Cervical Interbody Fusion Device

Primary DI
G079100121007T0
Brand
Advantage C Cervical Interbody Fusion Device
Company
Intelivation, LLC
Model
1001.21007T
Device description
Advantage-C™, Trial,12x14x7/8m,10deg
Published
2026-02-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G079100121007T0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Spinal implant trialA copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
037368183
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G079IVA22025000Golden Isles Pedicle Screw SystemIVA-2202-5002026-07-10
G079IVA22026000Golden Isles Pedicle Screw SystemIVA-2202-6002026-07-10
G079PDG2000Advantage-C Ti3D, Cervical InterbodyPDG-2002026-07-10
G079INL1390700Inlet Bone Fixation SystemINL-139-0702024-01-31
G079C2520000650Golden Isles Pedicle Screw SystemC25-2000-0652022-09-23
G079100140712S1Advantage C Cervical Interbody Fusion Device 1001.40712S2022-04-15
G079100150706S1Advantage C Cervical Interbody Fusion Device 1001.50706S2022-04-15
G079C5011000010Golden Isles Pedicle Screw SystemC50-1100-0012026-04-22
G079C5011000020Golden Isles Pedicle Screw SystemC50-1100-0022026-04-22
G079C5011000030Golden Isles Pedicle Screw SystemC50-1100-0032026-04-22
G079C5020000950Golden Isles Pedicle Screw SystemC50-2000-0952026-04-22
G079C5020001000Golden Isles Pedicle Screw SystemC50-2000-1002026-04-22
G079C5020001050Golden Isles Pedicle Screw SystemC50-2000-1052026-04-22
G079C5070000120Golden Isles Pedicle Screw SystemC50-7000-0122026-04-22
G079OSD000Golden Isles Pedicle Screw SystemOSD-002026-04-22
G079PAN0010Golden Isles Pedicle Screw SystemPAN-0012026-04-22
G079ADL120P28150Advantage -LUMBAR InterbodyADL-120P-28152026-04-20
G079ADL120P28160Advantage -LUMBAR InterbodyADL-120P-28162026-04-20
G079ADL120P32080Advantage -LUMBAR InterbodyADL-120P-32082026-04-20
G079ADL120P32090Advantage -LUMBAR InterbodyADL-120P-32092026-04-20

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Primary DI, Brand, Company table
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00822409082124N/AOrtho Development CorporationLXH2026-07-16
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00840606188135Ventana ASPINAL ELEMENTS, INC.LXH2026-07-16
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