MONDRIAN TLIF

GUDID 00841732151000

MONDRIAN TLIF Cage, Straight, Titanium feat TiCro, 0 Deg, W11xL32, H6mm

CTL Medical Corporation

Metallic spinal interbody fusion cage
Primary Device ID00841732151000
NIH Device Record Key79010e2a-ee21-49f2-9bd3-a03fe25b42cb
Commercial Distribution StatusIn Commercial Distribution
Brand NameMONDRIAN TLIF
Version Model Number127.1406
Company DUNS080138504
Company NameCTL Medical Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(214) 545-5820
Emailschedule@ctlamedica.com
Phone(214) 545-5820
Emailschedule@ctlamedica.com
Phone(214) 545-5820
Emailschedule@ctlamedica.com
Phone(214) 545-5820
Emailschedule@ctlamedica.com
Phone(214) 545-5820
Emailschedule@ctlamedica.com
Phone(214) 545-5820
Emailschedule@ctlamedica.com
Phone(214) 545-5820
Emailschedule@ctlamedica.com
Phone(214) 545-5820
Emailschedule@ctlamedica.com
Phone(214) 545-5820
Emailschedule@ctlamedica.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841732151000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral fusion device with bone graft, lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00841732151000]

Moist Heat or Steam Sterilization


[00841732151000]

Moist Heat or Steam Sterilization


[00841732151000]

Moist Heat or Steam Sterilization


[00841732151000]

Moist Heat or Steam Sterilization


[00841732151000]

Moist Heat or Steam Sterilization


[00841732151000]

Moist Heat or Steam Sterilization


[00841732151000]

Moist Heat or Steam Sterilization


[00841732151000]

Moist Heat or Steam Sterilization


[00841732151000]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-06
Device Publish Date2025-05-29

On-Brand Devices [MONDRIAN TLIF]

00841732151017MONDRIAN TLIF Cage, Straight, Titanium feat TiCro, 15 Deg, W11xL22, H6mm
00841732151000MONDRIAN TLIF Cage, Straight, Titanium feat TiCro, 0 Deg, W11xL32, H6mm
00841732150997MONDRIAN TLIF Cage, Straight, Titanium feat TiCro, 0 Deg, W11xL28, H6mm

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