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 ID: 00841732111837
• NIH Device Record Key: 43b5d92e-fc0c-4682-950f-80d1c65f7292
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CEZANNE II Lumbar Interbody Fusion Cage System
• Version Model Number: 018.1113
• Company DUNS: 080138504
• Company Name: CTL MEDICAL CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841732111837 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131981

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[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 Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2016-03-10

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

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