FDA.reportPublic FDA data

MONDRIAN Lumbar Interbody Fusion Cage System

Primary DI
00841732122468
Brand
MONDRIAN Lumbar Interbody Fusion Cage System
Company
CTL Medical Corporation
Model
103.7155
Device description
Convex Paddle Disc Shaver, L32xH15mm
Published
2025-06-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K121567000
K192863000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121567000ORACLE LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEMAccel Spine2012-09-26MAX
K192863000MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation2020-08-26MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841732122468PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841732122468008417321224688417321224680841732122468

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(214)545-5820schedule@ctlmed.com
+1(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
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
00841732145528VALEO C+CSC with Lumen Interbody Fusion Device11.209.17082023-09-19
00841732145535VALEO C+CSC with Lumen Interbody Fusion Device11.209.17092023-09-19
00841732145542VALEO C+CSC with Lumen Interbody Fusion Device11.209.17102023-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017916184SABER-XA, Expandable Spacer, 37x28mm,13mm, (12°)ELEVATION SPINE, INC.MAX2026-10-01
10888857160460CASCADIA™ Interbody SystemVB Spine LLCMAX2018-04-16
10888857223769CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223776CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223783CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223790CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223868CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223875CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223882CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223899CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223967CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223974CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223981CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223998CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857217355CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217362CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217379CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217386CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217393CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217454CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217461CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217478CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217485CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217492CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217553CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217560CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217577CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217584CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217591CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217669CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19