CEZANNE Lumbar Interbody Fusion Cage System

GUDID 00841732111134

CEZANNE™ PLIF PEEK Cage, 4Deg., W11 x L28, H14mm

CTL MEDICAL CORPORATION

Polymeric spinal interbody fusion cage

• Primary Device ID: 00841732111134
• NIH Device Record Key: d668aad0-1bea-4783-84f9-8e22402d1265
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CEZANNE Lumbar Interbody Fusion Cage System
• Version Model Number: 017.0514
• 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 Dimensions

• Length: 28 Millimeter
• Length: 28 Millimeter
• Length: 28 Millimeter
• Length: 28 Millimeter
• Height: 14 Millimeter
• Width: 11 Millimeter
• Device Size Text, specify: 0
• Length: 28 Millimeter
• Height: 14 Millimeter
• Width: 11 Millimeter
• Device Size Text, specify: 0
• Length: 28 Millimeter
• Height: 14 Millimeter
• Width: 11 Millimeter
• Device Size Text, specify: 0
• Length: 28 Millimeter
• Height: 14 Millimeter
• Width: 11 Millimeter
• Device Size Text, specify: 0
• Length: 28 Millimeter
• Height: 14 Millimeter
• Width: 11 Millimeter
• Device Size Text, specify: 0
• Length: 28 Millimeter
• Height: 14 Millimeter
• Width: 11 Millimeter
• Device Size Text, specify: 0
• Length: 28 Millimeter
• Height: 14 Millimeter
• Width: 11 Millimeter
• Device Size Text, specify: 0
• Length: 28 Millimeter
• Height: 14 Millimeter
• Width: 11 Millimeter
• Device Size Text, specify: 0
• Length: 28 Millimeter
• Height: 14 Millimeter
• Width: 11 Millimeter
• Device Size Text, specify: 0
• Length: 28 Millimeter
• Height: 14 Millimeter
• Width: 11 Millimeter
• Device Size Text, specify: 0
• Length: 28 Millimeter
• Height: 14 Millimeter
• Width: 11 Millimeter
• Device Size Text, specify: 0
• Length: 28 Millimeter
• Height: 14 Millimeter
• Width: 11 Millimeter
• Device Size Text, specify: 0
• Length: 28 Millimeter
• Height: 14 Millimeter
• Width: 11 Millimeter
• Device Size Text, specify: 0
• Length: 28 Millimeter
• Height: 14 Millimeter
• Width: 11 Millimeter
• Device Size Text, specify: 0
• Length: 28 Millimeter
• Height: 14 Millimeter
• Width: 11 Millimeter
• Device Size Text, specify: 0
• Length: 28 Millimeter
• Height: 14 Millimeter
• Width: 11 Millimeter
• Device Size Text, specify: 0
• Length: 28 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841732111134 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121567

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[00841732111134]

Moist Heat or Steam Sterilization

[00841732111134]

Moist Heat or Steam Sterilization

[00841732111134]

Moist Heat or Steam Sterilization

[00841732111134]

Moist Heat or Steam Sterilization

[00841732111134]

Moist Heat or Steam Sterilization

[00841732111134]

Moist Heat or Steam Sterilization

[00841732111134]

Moist Heat or Steam Sterilization

[00841732111134]

Moist Heat or Steam Sterilization

[00841732111134]

Moist Heat or Steam Sterilization

[00841732111134]

Moist Heat or Steam Sterilization

[00841732111134]

Moist Heat or Steam Sterilization

[00841732111134]

Moist Heat or Steam Sterilization

[00841732111134]

Moist Heat or Steam Sterilization

[00841732111134]

Moist Heat or Steam Sterilization

[00841732111134]

Moist Heat or Steam Sterilization

[00841732111134]

Moist Heat or Steam Sterilization

[00841732111134]

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: 2016-03-08

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

• 00841732111592: CEZANNE™ PLIF PEEK Cage, 8Deg., W11 x L32, H16mm
• 00841732111585: CEZANNE™ PLIF PEEK Cage, 8Deg., W11 x L32, H15mm
• 00841732111578: CEZANNE™ PLIF PEEK Cage, 8Deg., W11 x L32, H14mm
• 00841732111561: CEZANNE™ PLIF PEEK Cage, 8Deg., W11 x L32, H13mm
• 00841732111554: CEZANNE™ PLIF PEEK Cage, 8Deg., W11 x L32, H12mm
• 00841732111547: CEZANNE™ PLIF PEEK Cage, 8Deg., W11 x L32, H11mm
• 00841732111530: CEZANNE™ PLIF PEEK Cage, 8Deg., W11 x L32, H10mm
• 00841732111523: CEZANNE™ PLIF PEEK Cage, 8Deg., W11 x L32, H9mm
• 00841732111516: CEZANNE™ PLIF PEEK Cage, 8Deg., W11 x L32, H8mm
• 00841732111509: CEZANNE™ PLIF PEEK Cage, 8Deg., W11 x L32, H7mm
• 00841732111493: CEZANNE™ PLIF PEEK Cage, 8Deg., W11 x L32, H6mm
• 00841732111486: CEZANNE™ PLIF PEEK Cage, 4Deg., W11 x L32, H16mm
• 00841732111479: CEZANNE™ PLIF PEEK Cage, 4Deg., W11 x L32, H15mm
• 00841732111462: CEZANNE™ PLIF PEEK Cage, 4Deg., W11 x L32, H14mm
• 00841732111455: CEZANNE™ PLIF PEEK Cage, 4Deg., W11 x L32, H13mm
• 00841732111448: CEZANNE™ PLIF PEEK Cage, 4Deg., W11 x L32, H12mm
• 00841732111431: CEZANNE™ PLIF PEEK Cage, 4Deg., W11 x L32, H11mm
• 00841732111424: CEZANNE™ PLIF PEEK Cage, 4Deg., W11 x L32, H10mm
• 00841732111417: CEZANNE™ PLIF PEEK Cage, 4Deg., W11 x L32, H9mm
• 00841732111400: CEZANNE™ PLIF PEEK Cage, 4Deg., W11 x L32, H8mm
• 00841732111394: CEZANNE™ PLIF PEEK Cage, 4Deg., W11 x L32, H7mm
• 00841732111387: CEZANNE™ PLIF PEEK Cage, 4Deg., W11 x L32, H6mm
• 00841732111370: CEZANNE™ PLIF PEEK Cage, 0Deg., W11 x L32, H16mm
• 00841732111363: CEZANNE™ PLIF PEEK Cage, 0Deg., W11 x L32, H15mm
• 00841732111356: CEZANNE™ PLIF PEEK Cage, 0Deg., W11 x L32, H14mm
• 00841732111349: CEZANNE™ PLIF PEEK Cage, 0Deg., W11 x L32, H13mm
• 00841732111332: CEZANNE™ PLIF PEEK Cage, 0Deg., W11 x L32, H12mm
• 00841732111325: CEZANNE™ PLIF PEEK Cage, 0Deg., W11 x L32, H11mm
• 00841732111318: CEZANNE™ PLIF PEEK Cage, 0Deg., W11 x L32, H10mm
• 00841732111301: CEZANNE™ PLIF PEEK Cage, 0Deg., W11 x L32, H9mm
• 00841732111295: CEZANNE™ PLIF PEEK Cage, 0Deg., W11 x L32, H8mm
• 00841732111288: CEZANNE™ PLIF PEEK Cage, 0Deg., W11 x L32, H7mm
• 00841732111271: CEZANNE™ PLIF PEEK Cage, 0Deg., W11 x L32, H6mm
• 00841732111264: CEZANNE™ PLIF PEEK Cage, 8Deg., W11 x L28, H16mm
• 00841732111257: CEZANNE™ PLIF PEEK Cage, 8Deg., W11 x L28, H15mm
• 00841732111240: CEZANNE™ PLIF PEEK Cage, 8Deg., W11 x L28, H14mm
• 00841732111233: CEZANNE™ PLIF PEEK Cage, 8Deg., W11 x L28, H13mm
• 00841732111226: CEZANNE™ PLIF PEEK Cage, 8Deg., W11 x L28, H12mm
• 00841732111219: CEZANNE™ PLIF PEEK Cage, 8Deg., W11 x L28, H11mm
• 00841732111202: CEZANNE™ PLIF PEEK Cage, 8Deg., W11 x L28, H10mm
• 00841732111196: CEZANNE™ PLIF PEEK Cage, 8Deg., W11 x L28, H9mm
• 00841732111189: CEZANNE™ PLIF PEEK Cage, 8Deg., W11 x L28, H8mm
• 00841732111172: CEZANNE™ PLIF PEEK Cage, 8Deg., W11 x L28, H7mm
• 00841732111165: CEZANNE™ PLIF PEEK Cage, 8Deg., W11 x L28, H6mm
• 00841732111158: CEZANNE™ PLIF PEEK Cage, 4Deg., W11 x L28, H16mm
• 00841732111141: CEZANNE™ PLIF PEEK Cage, 4Deg., W11 x L28, H15mm
• 00841732111134: CEZANNE™ PLIF PEEK Cage, 4Deg., W11 x L28, H14mm
• 00841732111127: CEZANNE™ PLIF PEEK Cage, 4Deg., W11 x L28, H13mm
• 00841732111110: CEZANNE™ PLIF PEEK Cage, 4Deg., W11 x L28, H12mm
• 00841732111103: CEZANNE™ PLIF PEEK Cage, 4Deg., W11 x L28, H11mm