FDA.reportPublic FDA data

MONDRIAN Lumbar Interbody Fusion Cage System

Primary DI
00841732124806
Brand
MONDRIAN Lumbar Interbody Fusion Cage System
Company
CTL Medical Corporation
Model
103.7166
Device description
Convex TLIF Disc Shaver, L28xH16mm
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
00841732124806PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841732124806008417321248068417321248060841732124806

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
00841732155671VALEO II PL OL Interbody Fusion System12.301.10122023-09-27
00841732155688VALEO II PL OL Interbody Fusion System12.301.10132023-09-27
00841732155695VALEO II PL OL Interbody Fusion System12.301.10152023-09-27
00841732155701VALEO II PL OL Interbody Fusion System12.301.10142023-09-27
00841732155718VALEO II PL OL Interbody Fusion System12.301.10162023-09-27
00841732155725VALEO II PL OL Interbody Fusion System12.301.15082023-09-27
00841732155732VALEO II PL OL Interbody Fusion System12.301.15092023-09-27
00841732155749VALEO II PL OL Interbody Fusion System12.301.15102023-09-27
00841732155756VALEO II PL OL Interbody Fusion System12.301.15112023-09-27
00841732155763VALEO II PL OL Interbody Fusion System12.301.15122023-09-27
00841732155770VALEO II PL OL Interbody Fusion System12.301.15132023-09-27
00841732155787VALEO II PL OL Interbody Fusion System12.301.15142023-09-27
00841732155794VALEO II PL OL Interbody Fusion System12.301.15152023-09-27
00841732155800VALEO II PL OL Interbody Fusion System12.301.15162023-09-27
00841732156135VALEO II PL OL Interbody Fusion System12.301.20072023-09-27
00841732156142VALEO II PL OL Interbody Fusion System12.301.20082023-09-27
00841732156159VALEO II PL OL Interbody Fusion System12.301.20092023-09-27
00841732156166VALEO II PL OL Interbody Fusion System12.301.20102023-09-27
00841732156173VALEO II PL OL Interbody Fusion System12.301.20112023-09-27
00841732156180VALEO II PL OL Interbody Fusion System12.301.20122023-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800043966040N/ATDM Co., Ltd.MAX2026-06-08
08800043966057N/ATDM Co., Ltd.MAX2026-06-08
08800043966064N/ATDM Co., Ltd.MAX2026-06-08
08800043966071N/ATDM Co., Ltd.MAX2026-06-08
08800043966088N/ATDM Co., Ltd.MAX2026-06-08
08800043966095N/ATDM Co., Ltd.MAX2026-06-08
08800043966101N/ATDM Co., Ltd.MAX2026-06-08
08800043966118N/ATDM Co., Ltd.MAX2026-06-08
08800043966125N/ATDM Co., Ltd.MAX2026-06-08
08800043966132N/ATDM Co., Ltd.MAX2026-06-08
08800043966149N/ATDM Co., Ltd.MAX2026-06-08
08800043966156N/ATDM Co., Ltd.MAX2026-06-08
08800043966163N/ATDM Co., Ltd.MAX2026-06-08
08800043966170N/ATDM Co., Ltd.MAX2026-06-08
08800043966187N/ATDM Co., Ltd.MAX2026-06-08
08800043966194N/ATDM Co., Ltd.MAX2026-06-08
08800043966200N/ATDM Co., Ltd.MAX2026-06-08
08800043966217N/ATDM Co., Ltd.MAX2026-06-08
08800043966224N/ATDM Co., Ltd.MAX2026-06-08
08800043966231N/ATDM Co., Ltd.MAX2026-06-08
08800043966248N/ATDM Co., Ltd.MAX2026-06-08
08800043966255N/ATDM Co., Ltd.MAX2026-06-08
08800043966262N/ATDM Co., Ltd.MAX2026-06-08
08800043966279N/ATDM Co., Ltd.MAX2026-06-08
08800043966286N/ATDM Co., Ltd.MAX2026-06-08
08800043966293N/ATDM Co., Ltd.MAX2026-06-08
08800043966309N/ATDM Co., Ltd.MAX2026-06-08
08800043966316N/ATDM Co., Ltd.MAX2026-06-08
08800043966323N/ATDM Co., Ltd.MAX2026-06-08
08800043966330N/ATDM Co., Ltd.MAX2026-06-08