CEZANNE-II

GUDID 00841732124974

CTL MEDICAL CORPORATION

Polymeric spinal interbody fusion cage

• Primary Device ID: 00841732124974
• NIH Device Record Key: fb7dcae0-7342-4a69-8c42-29dbf1127c71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CEZANNE-II
• Version Model Number: 128.5429
• 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: false
• 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	00841732124974 [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: true

[00841732124974]

Moist Heat or Steam Sterilization

[00841732124974]

Moist Heat or Steam Sterilization

[00841732124974]

Moist Heat or Steam Sterilization

[00841732124974]

Moist Heat or Steam Sterilization

[00841732124974]

Moist Heat or Steam Sterilization

[00841732124974]

Moist Heat or Steam Sterilization

[00841732124974]

Moist Heat or Steam Sterilization

[00841732124974]

Moist Heat or Steam Sterilization

[00841732124974]

Moist Heat or Steam Sterilization

[00841732124974]

Moist Heat or Steam Sterilization

[00841732124974]

Moist Heat or Steam Sterilization

[00841732124974]

Moist Heat or Steam Sterilization

[00841732124974]

Moist Heat or Steam Sterilization

[00841732124974]

Moist Heat or Steam Sterilization

[00841732124974]

Moist Heat or Steam Sterilization

[00841732124974]

Moist Heat or Steam Sterilization

[00841732124974]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-24
• Device Publish Date: 2019-10-29

On-Brand Devices [CEZANNE-II]

• 00841732123977: 018.5314
• 00841732123960: 018.5312
• 00841732123953: 018.5310
• 00841732123946: 018.5214
• 00841732123939: 018.5212
• 00841732123922: 018.5210
• 00841732123915: 018.5114
• 00841732123908: 018.5112
• 00841732123892: 018.5110
• 00841732125384: 128.4035
• 00841732125377: 128.4034
• 00841732125360: 128.4033
• 00841732125353: 128.4032
• 00841732125346: 128.4031
• 00841732125339: 128.4030
• 00841732125322: 128.4029
• 00841732125315: 128.4028
• 00841732124981: 128.5430
• 00841732124974: 128.5429
• 00841732124967: 128.5428
• 00841732124950: 128.5330
• 00841732124943: 128.5329
• 00841732124936: 128.5328
• 00841732123700: 128.5230
• 00841732123694: 128.5229
• 00841732123687: 128.5228