FDA.reportPublic FDA data

Ti-Diagon Oblique TLIF

Primary DI
B030DIT221115110
Brand
Ti-Diagon Oblique TLIF
Company
CAMBER SPINE TECHNOLOGIES, LLC
Model
DIT-2211-1511
Device description
TLIF Implant, 22mm x 11mm, 11mm, 15° Lordotic
Published
2018-04-20
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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172064000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172064000Ti-Diagon Oblique TLIFCamber Spine Technologies2017-09-15MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B030DIT221115110PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Metallic spinal fusion cage, non-sterileA non-sterile device intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically designed as a small, hollow and/or porous, threaded or fenestrated cylinder (or other geometric form) made of metal [usually titanium (Ti)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for therapeutic spinal bone fusion to occur. Disposable devices associated with implantation may be included. This device must be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-866-643-0739customerservice@cambermedtech.com

Regulatory Flags#

DUNS number
054205979
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B030SPO1530020VARIANTSPO-153-0022022-11-25
B030TLP420WR0Alcantara™ Thoracolumbar PlatingTLP-420WR2025-08-01
B030TLP422WR0Alcantara™ Thoracolumbar PlatingTLP-422WR2025-08-01
B030TLP424WR0Alcantara™ Thoracolumbar PlatingTLP-424WR2025-08-01
B030TLP426WR0Alcantara™ Thoracolumbar PlatingTLP-426WR2025-08-01
B030TLP428WR0Alcantara™ Thoracolumbar PlatingTLP-428WR2025-08-01
B030TLP430WR0Alcantara™ Thoracolumbar PlatingTLP-430WR2025-08-01
B030TLP432WR0Alcantara™ Thoracolumbar PlatingTLP-432WR2025-08-01
B030TLP434WR0Alcantara™ Thoracolumbar PlatingTLP-434WR2025-08-01
B030TLP436WR0Alcantara™ Thoracolumbar PlatingTLP-436WR2025-08-01
B030TLP438WR0Alcantara™ Thoracolumbar PlatingTLP-438WR2025-08-01
B030TLP440WR0Alcantara™ Thoracolumbar PlatingTLP-440WR2025-08-01
B030TLP1000Alcantara Thoracolumbar PlatingTLP-100NA2024-07-18
B030TLP2180Alcantara Thoracolumbar PlatingTLP-218NA2024-07-18
B030TLP2200Alcantara Thoracolumbar PlatingTLP-220NA2024-07-18
B030TLP2220Alcantara Thoracolumbar PlatingTLP-222NA2024-07-18
B030TLP2240Alcantara Thoracolumbar PlatingTLP-224NA2024-07-18
B030TLP2260Alcantara Thoracolumbar PlatingTLP-226NA2024-07-18
B030TLP2280Alcantara Thoracolumbar PlatingTLP-228NA2024-07-18
B030TLP2350Alcantara Thoracolumbar PlatingTLP-235NA2024-07-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00843511102173Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102180Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102197Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102203Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102210Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102227Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102234Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102241Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102258Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102265Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102272Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102289Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102296Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102302Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102319Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102326Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102333Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102340Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102357Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102364Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102371Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102388Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102395Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102401Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102418Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22