FDA.reportPublic FDA data

MONDRIAN ALIF Cage with Supplementary Fixation Plate

Primary DI
00841732168770
Brand
MONDRIAN ALIF Cage with Supplementary Fixation Plate
Company
CTL Medical Corporation
Model
120.1915
Device description
MONDRIAN ALIF Cage with Plate Assembly, Titanium, W39xL26, 9 degrees, H15mm
Published
2026-01-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MAXIntervertebral Fusion Device With Bone Graft, Lumbar
OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213641000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213641000MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation2022-09-15MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841732168770PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841732168770008417321687708417321687700841732168770

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
214-545-5820schedule@ctlamedica.com

Regulatory Flags#

DUNS number
080138504
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
00841732169371TAURUS LX Pedicle Screw System159.72512026-11-04
00841732169258MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation113.75132026-11-02
00841732169265MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation113.75142026-11-02
00841732168091MONDRIAN ALIF Cage with Supplementary Fixation Plate120.87002026-08-14
00841732168107MONDRIAN ALIF Cage with Supplementary Fixation Plate120.87042026-08-14
00841732168114MONDRIAN ALIF Cage with Supplementary Fixation Plate120.87012026-08-14
00841732168121MONDRIAN ALIF Cage with Supplementary Fixation Plate120.87022026-08-14
00841732168138MONDRIAN ALIF Cage with Supplementary Fixation Plate120.87032026-08-14
00841732168527TAURUS Pedicle Screw System059.80132026-07-28
00841732169272PICASSO MIS Spinal System016.31602026-07-24
00841732169289PICASSO MIS Spinal System016.31702026-07-24
00841732169296PICASSO MIS Spinal System016.31802026-07-24
00841732169302PICASSO MIS Spinal System016.31902026-07-24
00841732169319PICASSO MIS Spinal System016.32002026-07-24
00841732163447VALEO C Spacer System91.002.40012023-09-30
00841732163454VALEO C Spacer System91.002.40022023-09-30
00841732163461VALEO C Spacer System91.002.40032023-09-30
00841732128231VALEO VBR91.009.56512023-09-27
00841732128248VALEO VBR91.009.56522023-09-27
00841732145511VALEO C+CSC with Lumen Interbody Fusion Device11.209.17072023-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08809974858455Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858462Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858479Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858486Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858493Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858509Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858516Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858523Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858530Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858547Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858554Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858561Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858578Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858585Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858592Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858608Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858615Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858622Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858639Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858646Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858653Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858660Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858677Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858684Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858691Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858707Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858714Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19