TAURUS Pedicle Screw System

GUDID 00841732144040

INLINE TORQUE LIMITING HANDLE 40 IN-LBS (GRAY)

CTL Medical Corporation

General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit

• Primary Device ID: 00841732144040
• NIH Device Record Key: 1b0964f7-92fa-4df5-90b6-28eec902811e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TAURUS Pedicle Screw System
• Version Model Number: 059.7128.GY
• 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: true
• 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: schedule@ctlamedica.com
• Phone: 1 (214) 545-5820
• Email: schedule@ctlamedica.com
• Phone: 1 (214) 545-5820
• Email: schedule@ctlamedica.com
• Phone: 1 (214) 545-5820
• Email: schedule@ctlamedica.com
• Phone: 1 (214) 545-5820
• Email: schedule@ctlamedica.com
• Phone: 1 (214) 545-5820
• Email: schedule@ctlamedica.com
• Phone: 1 (214) 545-5820
• Email: schedule@ctlamedica.com
• Phone: 1 (214) 545-5820
• Email: schedule@ctlamedica.com
• Phone: 1 (214) 545-5820
• Email: schedule@ctlamedica.com
• Phone: 1 (214) 545-5820
• Email: schedule@ctlamedica.com
• Phone: 1 (214) 545-5820
• Email: schedule@ctlamedica.com
• Phone: 1 (214) 545-5820
• Email: schedule@ctlamedica.com
• Phone: 1 (214) 545-5820
• Email: schedule@ctlamedica.com
• Phone: 1 (214) 545-5820
• Email: schedule@ctlamedica.com
• Phone: 1 (214) 545-5820
• Email: schedule@ctlamedica.com
• Phone: 1 (214) 545-5820
• Email: schedule@ctlamedica.com
• Phone: 1 (214) 545-5820
• Email: schedule@ctlamedica.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841732144040 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162160

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[00841732144040]

Moist Heat or Steam Sterilization

[00841732144040]

Moist Heat or Steam Sterilization

[00841732144040]

Moist Heat or Steam Sterilization

[00841732144040]

Moist Heat or Steam Sterilization

[00841732144040]

Moist Heat or Steam Sterilization

[00841732144040]

Moist Heat or Steam Sterilization

[00841732144040]

Moist Heat or Steam Sterilization

[00841732144040]

Moist Heat or Steam Sterilization

[00841732144040]

Moist Heat or Steam Sterilization

[00841732144040]

Moist Heat or Steam Sterilization

[00841732144040]

Moist Heat or Steam Sterilization

[00841732144040]

Moist Heat or Steam Sterilization

[00841732144040]

Moist Heat or Steam Sterilization

[00841732144040]

Moist Heat or Steam Sterilization

[00841732144040]

Moist Heat or Steam Sterilization

[00841732144040]

Moist Heat or Steam Sterilization

[00841732144040]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-01
• Device Publish Date: 2024-06-21

On-Brand Devices [TAURUS Pedicle Screw System]

• 00841732144040: INLINE TORQUE LIMITING HANDLE 40 IN-LBS (GRAY)
• 00841732134720: CROSS CONNECTOR CADDY