CEZANNE II

GUDID 00841732128033

CEZANNE-II™ DLIF PEEK Cage, 8Deg., W19 x L50, H13mm

CTL MEDICAL CORPORATION

Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage

• Primary Device ID: 00841732128033
• NIH Device Record Key: 477d8488-c126-46a1-bce3-8d286abb4105
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CEZANNE II
• Version Model Number: 018.3213
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841732128033 [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

[00841732128033]

Moist Heat or Steam Sterilization

[00841732128033]

Moist Heat or Steam Sterilization

[00841732128033]

Moist Heat or Steam Sterilization

[00841732128033]

Moist Heat or Steam Sterilization

[00841732128033]

Moist Heat or Steam Sterilization

[00841732128033]

Moist Heat or Steam Sterilization

[00841732128033]

Moist Heat or Steam Sterilization

[00841732128033]

Moist Heat or Steam Sterilization

[00841732128033]

Moist Heat or Steam Sterilization

[00841732128033]

Moist Heat or Steam Sterilization

[00841732128033]

Moist Heat or Steam Sterilization

[00841732128033]

Moist Heat or Steam Sterilization

[00841732128033]

Moist Heat or Steam Sterilization

[00841732128033]

Moist Heat or Steam Sterilization

[00841732128033]

Moist Heat or Steam Sterilization

[00841732128033]

Moist Heat or Steam Sterilization

[00841732128033]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-18
• Device Publish Date: 2023-10-10

On-Brand Devices [CEZANNE II]

• 00841732139558: CEZANNE-II™ DLIF PEEK Cage, 0Deg., W19 x L45, H11mm
• 00841732139541: CEZANNE-II™ DLIF PEEK Cage, 0Deg., W19 x L45, H10mm
• 00841732139534: CEZANNE-II™ DLIF PEEK Cage, 0Deg., W19 x L45, H9mm
• 00841732139527: CEZANNE-II™ DLIF PEEK Cage, 0Deg., W19 x L45, H8mm
• 00841732139510: CEZANNE-II™ DLIF PEEK Cage, 0Deg., W19 x L40, H16mm
• 00841732139503: CEZANNE-II™ DLIF PEEK Cage, 0Deg., W19 x L40, H15mm
• 00841732139497: CEZANNE-II™ DLIF PEEK Cage, 0Deg., W19 x L40, H14mm
• 00841732139480: CEZANNE-II™ DLIF PEEK Cage, 0Deg., W19 x L40, H13mm
• 00841732137509: CEZANNE-II™ DLIF PEEK Cage, 0Deg., W19 x L40, H12mm
• 00841732137493: CEZANNE-II™ DLIF PEEK Cage, 0Deg., W19 x L40, H11mm
• 00841732137486: CEZANNE-II™ DLIF PEEK Cage, 0Deg., W19 x L40, H10mm
• 00841732137462: CEZANNE-II™ DLIF PEEK Cage, 0Deg., W19 x L40, H9mm
• 00841732134331: CEZANNE-II™ DLIF PEEK Cage, 8Deg., W19 x L50, H15mm
• 00841732129368: CEZANNE-II™ DLIF PEEK Cage, 8Deg., W19 x L50, H14mm
• 00841732128033: CEZANNE-II™ DLIF PEEK Cage, 8Deg., W19 x L50, H13mm
• 00841732128002: CEZANNE-II™ DLIF PEEK Cage, 8Deg., W19 x L50, H12mm
• 00841732127999: CEZANNE-II™ DLIF PEEK Cage, 8Deg., W19 x L50, H11mm
• 00841732127982: CEZANNE-II™ DLIF PEEK Cage, 8Deg., W19 x L50, H10mm
• 00841732125407: CEZANNE-II™ DLIF PEEK Cage, 0Deg., W19 x L40, H8mm
• 00841732114678: CEZANNE-II™ DLIF PEEK Cage, 8Deg., W19 x L45, H15mm
• 00841732114661: CEZANNE-II™ DLIF PEEK Cage, 8Deg., W19 x L45, H16mm
• 00841732114654: CEZANNE-II™ DLIF PEEK Cage, 8Deg., W19 x L50, H9mm
• 00841732114647: CEZANNE-II™ DLIF PEEK Cage, 0Deg., W19 x L55, H8mm
• 00841732114630: CEZANNE-II™ DLIF PEEK Cage, 8Deg., W19 x L45, H14mm
• 00841732114623: CEZANNE-II™ DLIF PEEK Cage, 8Deg., W19 x L50, H8mm
• 00841732114616: CEZANNE-II™ DLIF PEEK Cage, 0Deg., W19 x L50, H16mm
• 00841732114609: CEZANNE-II™ DLIF PEEK Cage, 8Deg., W19 x L45, H12mm
• 00841732114593: CEZANNE-II™ DLIF PEEK Cage, 8Deg., W19 x L45, H13mm
• 00841732144637: CEZANNE-II™ DLIF PEEK Cage, 0Deg., W19 x L55, H10mm
• 00841732140943: CEZANNE-II™ DLIF PEEK Cage, 8Deg., W19 x L50, H16mm
• 00841732139756: CEZANNE-II™ DLIF PEEK Cage, 0Deg., W19 x L50, H11mm
• 00841732139633: CEZANNE-II™ DLIF PEEK Cage, 0Deg., W19 x L50, H10mm
• 00841732139626: CEZANNE-II™ DLIF PEEK Cage, 0Deg., W19 x L50, H9mm
• 00841732139619: CEZANNE-II™ DLIF PEEK Cage, 0Deg., W19 x L50, H8mm
• 00841732139602: CEZANNE-II™ DLIF PEEK Cage, 0Deg., W19 x L45, H16mm
• 00841732139596: CEZANNE-II™ DLIF PEEK Cage, 0Deg., W19 x L45, H15mm
• 00841732139589: CEZANNE-II™ DLIF PEEK Cage, 0Deg., W19 x L45, H14mm
• 00841732139572: CEZANNE-II™ DLIF PEEK Cage, 0Deg., W19 x L45, H13mm
• 00841732139565: CEZANNE-II™ DLIF PEEK Cage, 0Deg., W19 x L45, H12mm