Mondrian ALIF

GUDID 00841732167391

INSERTER TIP, PLATE-TRIAL

CTL Medical Corporation

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 00841732167391
• NIH Device Record Key: 25f31772-1541-45be-8f66-61d233749d0f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mondrian ALIF
• Version Model Number: 120.7605.D
• 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: false
• 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: 214-545-5820
• Email: schedule@ctlamedica.com
• Phone: 214-545-5820
• Email: schedule@ctlamedica.com
• Phone: 214-545-5820
• Email: schedule@ctlamedica.com
• Phone: 214-545-5820
• Email: schedule@ctlamedica.com
• Phone: 214-545-5820
• Email: schedule@ctlamedica.com
• Phone: 214-545-5820
• Email: schedule@ctlamedica.com
• Phone: 214-545-5820
• Email: schedule@ctlamedica.com
• Phone: 214-545-5820
• Email: schedule@ctlamedica.com
• Phone: 214-545-5820
• Email: schedule@ctlamedica.com
• Phone: 214-545-5820
• Email: schedule@ctlamedica.com
• Phone: 214-545-5820
• Email: schedule@ctlamedica.com
• Phone: 214-545-5820
• Email: schedule@ctlamedica.com
• Phone: 214-545-5820
• Email: schedule@ctlamedica.com
• Phone: 214-545-5820
• Email: schedule@ctlamedica.com
• Phone: 214-545-5820
• Email: schedule@ctlamedica.com
• Phone: 214-545-5820
• Email: schedule@ctlamedica.com
• Phone: 214-545-5820
• Email: schedule@ctlamedica.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841732167391 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192863

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[00841732167391]

Moist Heat or Steam Sterilization

[00841732167391]

Moist Heat or Steam Sterilization

[00841732167391]

Moist Heat or Steam Sterilization

[00841732167391]

Moist Heat or Steam Sterilization

[00841732167391]

Moist Heat or Steam Sterilization

[00841732167391]

Moist Heat or Steam Sterilization

[00841732167391]

Moist Heat or Steam Sterilization

[00841732167391]

Moist Heat or Steam Sterilization

[00841732167391]

Moist Heat or Steam Sterilization

[00841732167391]

Moist Heat or Steam Sterilization

[00841732167391]

Moist Heat or Steam Sterilization

[00841732167391]

Moist Heat or Steam Sterilization

[00841732167391]

Moist Heat or Steam Sterilization

[00841732167391]

Moist Heat or Steam Sterilization

[00841732167391]

Moist Heat or Steam Sterilization

[00841732167391]

Moist Heat or Steam Sterilization

[00841732167391]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-31
• Device Publish Date: 2025-01-23

Devices Manufactured by CTL Medical Corporation

• 00841732167803 - KLIMT: 2025-02-11 Expansion Driver, T10, Spring Loaded, STND
• 00841732167810 - KLIMT: 2025-02-11 Driver, T10
• 00841732167568 - Cezanne-II: 2025-02-04 CEZANNE-II DLIF Trial, 8°, W19 x L60, H10mm
• 00841732167575 - Cezanne-II: 2025-02-04 CEZANNE-II DLIF Trial, 8°, W19 x L60, H12mm
• 00841732167582 - Cezanne-II: 2025-02-04 CEZANNE-II DLIF Trial, 8°, W19 x L60, H14mm
• 00841732167599 - Cezanne-II: 2025-02-04 CEZANNE-II DLIF Trial, 12°, W19 x L60, H10mm
• 00841732167605 - Cezanne-II: 2025-02-04 CEZANNE-II DLIF Trial, 12°, W19 x L60, H12mm
• 00841732167612 - Cezanne-II: 2025-02-04 CEZANNE-II DLIF Trial, 12°, W19 x L60, H14mm