CEZANNE-II

GUDID 00841732125339

CTL MEDICAL CORPORATION

Polymeric spinal interbody fusion cage

• Primary Device ID: 00841732125339
• NIH Device Record Key: a9a57982-e284-47a3-95f7-840c5bc9b15f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CEZANNE-II
• Version Model Number: 128.4030
• 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	00841732125339 [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

[00841732125339]

Moist Heat or Steam Sterilization

[00841732125339]

Moist Heat or Steam Sterilization

[00841732125339]

Moist Heat or Steam Sterilization

[00841732125339]

Moist Heat or Steam Sterilization

[00841732125339]

Moist Heat or Steam Sterilization

[00841732125339]

Moist Heat or Steam Sterilization

[00841732125339]

Moist Heat or Steam Sterilization

[00841732125339]

Moist Heat or Steam Sterilization

[00841732125339]

Moist Heat or Steam Sterilization

[00841732125339]

Moist Heat or Steam Sterilization

[00841732125339]

Moist Heat or Steam Sterilization

[00841732125339]

Moist Heat or Steam Sterilization

[00841732125339]

Moist Heat or Steam Sterilization

[00841732125339]

Moist Heat or Steam Sterilization

[00841732125339]

Moist Heat or Steam Sterilization

[00841732125339]

Moist Heat or Steam Sterilization

[00841732125339]

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: 2019-10-28

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
• 00841732167308: CEZANNE-II DLIF TRIAL, 6DEG, W22 x L60, H8MM
• 00841732167292: CEZANNE-II DLIF TRIAL, 6DEG, W22 x L60, H10MM
• 00841732167285: CEZANNE-II DLIF TRIAL, 6DEG, W22 x L60, H12MM
• 00841732167278: CEZANNE-II DLIF TRIAL, 6DEG, W22 x L60, H14MM
• 00841732167261: CEZANNE-II DLIF TRIAL, 6DEG, W22 x L60, H16MM
• 00841732167254: CEZANNE-II DLIF Cage Inserter, Straight, Short
• 00841732167247: CEZANNE-II DLIF Initial Distractor, 0° W19 x L60, H4mm, Short
• 00841732167230: CEZANNE-II DLIF Initial Distractor, 0° W19 x L60, H6mm, Short
• 00841732167223: CEZANNE-II DLIF Trial, 12° W19 x L60, H14mm
• 00841732167216: CEZANNE-II DLIF Trial, 12° W19 x L60, H12mm
• 00841732167209: CEZANNE-II DLIF Trial, 12° W19 x L60, H10mm
• 00841732167193: CEZANNE-II DLIF Trial, 12° W19 x L60, H8mm
• 00841732167186: CEZANNE-II DLIF Trial, 8° W19 x L60, H14mm
• 00841732167179: CEZANNE-II DLIF Trial, 8° W19 x L60, H12mm
• 00841732167162: CEZANNE-II DLIF Trial, 8° W19 x L60, H10mm
• 00841732167155: CEZANNE-II DLIF Trial, 8° W19 x L60, H8mm
• 00841732167148: CEZANNE-II DLIF Trial, 0° W19 x L60, H14mm
• 00841732167131: CEZANNE-II DLIF Trial, 0° W19 x L60, H12mm
• 00841732167124: CEZANNE-II DLIF Trial, 0° W19 x L60, H10mm
• 00841732167117: CEZANNE-II DLIF Trial, 0° W19 x L60, H8mm