CEZANNE II Lumbar Interbody Fusion Cage System

GUDID 00841732111837

CEZANNE-II™ TLIF PEEK Cage, 0Deg., W11 x L26, H13mm

CTL MEDICAL CORPORATION

Polymeric spinal interbody fusion cage
Primary Device ID00841732111837
NIH Device Record Key43b5d92e-fc0c-4682-950f-80d1c65f7292
Commercial Distribution StatusIn Commercial Distribution
Brand NameCEZANNE II Lumbar Interbody Fusion Cage System
Version Model Number018.1113
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(214)545-5820
Emailcomplaints@ctlmed.com
Phone+1(214)545-5820
Emailcomplaints@ctlmed.com
Phone+1(214)545-5820
Emailcomplaints@ctlmed.com
Phone+1(214)545-5820
Emailcomplaints@ctlmed.com
Phone+1(214)545-5820
Emailcomplaints@ctlmed.com
Phone+1(214)545-5820
Emailcomplaints@ctlmed.com
Phone+1(214)545-5820
Emailcomplaints@ctlmed.com
Phone+1(214)545-5820
Emailcomplaints@ctlmed.com
Phone+1(214)545-5820
Emailcomplaints@ctlmed.com
Phone+1(214)545-5820
Emailcomplaints@ctlmed.com
Phone+1(214)545-5820
Emailcomplaints@ctlmed.com
Phone+1(214)545-5820
Emailcomplaints@ctlmed.com
Phone+1(214)545-5820
Emailcomplaints@ctlmed.com
Phone+1(214)545-5820
Emailcomplaints@ctlmed.com
Phone+1(214)545-5820
Emailcomplaints@ctlmed.com
Phone+1(214)545-5820
Emailcomplaints@ctlmed.com
Phone+1(214)545-5820
Emailcomplaints@ctlmed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841732111837 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral fusion device with bone graft, lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841732111837]

Moist Heat or Steam Sterilization


[00841732111837]

Moist Heat or Steam Sterilization


[00841732111837]

Moist Heat or Steam Sterilization


[00841732111837]

Moist Heat or Steam Sterilization


[00841732111837]

Moist Heat or Steam Sterilization


[00841732111837]

Moist Heat or Steam Sterilization


[00841732111837]

Moist Heat or Steam Sterilization


[00841732111837]

Moist Heat or Steam Sterilization


[00841732111837]

Moist Heat or Steam Sterilization


[00841732111837]

Moist Heat or Steam Sterilization


[00841732111837]

Moist Heat or Steam Sterilization


[00841732111837]

Moist Heat or Steam Sterilization


[00841732111837]

Moist Heat or Steam Sterilization


[00841732111837]

Moist Heat or Steam Sterilization


[00841732111837]

Moist Heat or Steam Sterilization


[00841732111837]

Moist Heat or Steam Sterilization


[00841732111837]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2016-03-10

On-Brand Devices [CEZANNE II Lumbar Interbody Fusion Cage System]

00841732113114Cage Impactor, Curved
00841732113107Cage Impactor
00841732113091PLIF Cage Inserter, W9xL22, W9xL24
00841732113084Curved Trial, 8Deg., W10xL32mm, H16mm
00841732113077Curved Trial, 8Deg., W10xL32mm, H15mm
00841732113060Curved Trial, 8Deg., W10xL32mm, H14mm
00841732113053Curved Trial, 8Deg., W10xL32mm, H13mm
00841732113046Curved Trial, 8Deg., W10xL32mm, H12mm
00841732113039Curved Trial, 8Deg., W10xL32mm, H11mm
00841732113022Curved Trial, 8Deg., W10xL32mm, H10mm
00841732113015Curved Trial, 8Deg., W10xL32mm, H9mm
00841732113008Curved Trial, 8Deg., W10xL32mm, H8mm
00841732112995Curved Trial, 8Deg., W10xL32mm, H7mm
00841732112988Curved Trial, 0Deg., W10xL32mm, H16mm
00841732112971Curved Trial, 0Deg., W10xL32mm, H15mm
00841732112964Curved Trial, 0Deg., W10xL32mm, H14mm
00841732112957Curved Trial, 0Deg., W10xL32mm, H13mm
00841732112940Curved Trial, 0Deg., W10xL32mm, H12mm
00841732112933Curved Trial, 0Deg., W10xL32mm, H11mm
00841732112926Curved Trial, 0Deg., W10xL32mm, H10mm
00841732112919Curved Trial, 0Deg., W10xL32mm, H9mm
00841732112902Curved Trial, 0Deg., W10xL32mm, H8mm
00841732112896Curved Trial, 0Deg., W10xL32mm, H7mm
00841732112889Trial, 8Deg., W10xL32mm, H16mm
00841732112872Trial, 8Deg., W10xL32mm, H15mm
00841732112865Trial, 8Deg., W10xL32mm, H14mm
00841732112858Trial, 8Deg., W10xL32mm, H13mm
00841732112841Trial, 8Deg., W10xL32mm, H12mm
00841732112834Trial, 8Deg., W10xL32mm, H11mm
00841732112827Trial, 8Deg., W10xL32mm, H10mm
00841732112810Trial, 8Deg., W10xL32mm, H9mm
00841732112803Trial, 8Deg., W10xL32mm, H8mm
00841732112797Trial, 8Deg., W10xL32mm, H7mm
00841732112780Trial, 0Deg., W10xL32mm, H16mm
00841732112773Trial, 0Deg., W10xL32mm, H15mm
00841732112766Trial, 0Deg., W10xL32mm, H14mm
00841732112759Trial, 0Deg., W10xL32mm, H13mm
00841732112742Trial, 0Deg., W10xL32mm, H12mm
00841732112735Trial, 0Deg., W10xL32mm, H11mm
00841732112728Trial, 0Deg., W10xL32mm, H10mm
00841732112711Trial, 0Deg., W10xL32mm, H9mm
00841732112704Trial, 0Deg., W10xL32mm, H8mm
00841732112698Trial, 0Deg., W10xL32mm, H7mm
00841732112681Paddle Disc Shaver, L30xH16mm
00841732112674Paddle Disc Shaver, L30xH15mm
00841732112667Paddle Disc Shaver, L30xH14mm
00841732112650Paddle Disc Shaver, L30xH13mm
00841732112643Paddle Disc Shaver, L30xH12mm
00841732112636Paddle Disc Shaver, L30xH11mm
00841732112629Paddle Disc Shaver, L30xH10mm

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