PREFERENCE

GUDID 00841732151758

8.2mm Polyaxial Screw 60mm Bronze

CTL Medical Corporation

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 00841732151758
• NIH Device Record Key: 38eb24fd-d289-4f80-91a6-8218b08377b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PREFERENCE
• Version Model Number: 25-8200-060
• 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	00841732151758 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081296

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[00841732151758]

Moist Heat or Steam Sterilization

[00841732151758]

Moist Heat or Steam Sterilization

[00841732151758]

Moist Heat or Steam Sterilization

[00841732151758]

Moist Heat or Steam Sterilization

[00841732151758]

Moist Heat or Steam Sterilization

[00841732151758]

Moist Heat or Steam Sterilization

[00841732151758]

Moist Heat or Steam Sterilization

[00841732151758]

Moist Heat or Steam Sterilization

[00841732151758]

Moist Heat or Steam Sterilization

[00841732151758]

Moist Heat or Steam Sterilization

[00841732151758]

Moist Heat or Steam Sterilization

[00841732151758]

Moist Heat or Steam Sterilization

[00841732151758]

Moist Heat or Steam Sterilization

[00841732151758]

Moist Heat or Steam Sterilization

[00841732151758]

Moist Heat or Steam Sterilization

[00841732151758]

Moist Heat or Steam Sterilization

[00841732151758]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-11
• Device Publish Date: 2024-10-03

On-Brand Devices [PREFERENCE]

• 00841732167094: 2.4mm Dia Pedicle Drill
• 00841732151222: Hook Transverse Process Right
• 00841732151215: Hook Transverse Process Left
• 00841732151208: Hook Pedicle Small
• 00841732151192: Hook Pedicle Large
• 00841732151185: Hook Laminar Small Narrow Blade (6mm wide)
• 00841732151178: Hook Laminar Small Wide Blade (9mm wide)
• 00841732151161: Hook Laminar Large Wide Blade (9mm wide)
• 00841732151154: Hook Laminar Large Medium Blade (6mm wide)
• 00841732152465: 8.2mm Polyaxial Screw 110mm Bronze
• 00841732152458: 8.2mm Polyaxial Screw 100mm Bronze
• 00841732152441: 8.2mm Polyaxial Screw 90mm Bronze
• 00841732152434: 8.2mm Polyaxial Screw 80mm Bronze
• 00841732152427: 8.2mm Monoaxial Screw 60mm Bronze
• 00841732152410: 8.2mm Monoaxial Screw 55mm Bronze
• 00841732152403: 8.2mm Monoaxial Screw 50mm Bronze
• 00841732152397: 8.2mm Monoaxial Screw 45mm Bronze
• 00841732152380: 8.2mm Monoaxial Screw 40mm Bronze
• 00841732152373: 8.2mm Monoaxial Screw 35mm Bronze
• 00841732151765: 8.2mm Polyaxial Screw 70mm Bronze
• 00841732151758: 8.2mm Polyaxial Screw 60mm Bronze
• 00841732151741: 8.2mm Polyaxial Screw 55mm Bronze
• 00841732151727: 8.2mm Polyaxial Screw 50mm Bronze
• 00841732151710: 8.2mm Polyaxial Screw 45mm Bronze
• 00841732151703: 8.2mm Polyaxial Screw 40mm Bronze
• 00841732151697: 8.2mm Polyaxial Screw 35mm Bronze
• 00841732151321: 5.5mm Block-style Clam Shell Connector
• 00841732151314: Side-to-side Connector Single 5.5mm - 6.0mm Rod
• 00841732151307: Side-to-side Connector Single 6.0mm Rod
• 00841732151291: Side-to-side Connector Single 5.5mm Rod
• 00841732151284: Side-to-side Connector Double 5.5mm Rod
• 00841732151277: Axial Connector 5.5mm Rod
• 00841732151147: Cross-connector 36mm Fixed
• 00841732151130: Cross-connector 34mm Fixed
• 00841732151123: Cross-connector 32mm Fixed
• 00841732151116: Cross-connector 30mm Fixed
• 00841732151109: Cross-connector 28mm Fixed
• 00841732153141: 4.5mm Monoaxial Triple-lead screw 45mm Magenta
• 00841732153134: 4.5mm Monoaxial Triple-lead screw 40mm Magenta
• 00841732153127: 4.5mm Monoaxial Triple-lead screw 35mm Magenta
• 00841732153110: 4.5mm Monoaxial Triple-lead screw 30mm Magenta
• 00841732153103: 4.5mm Monoaxial Triple-lead screw 25mm Magenta
• 00841732152472: 4.5mm Polyaxial Triple-lead screw 25mm Magenta
• 00841732152144: 4.5mm Monoaxial Screw 45mm Magenta
• 00841732152137: 4.5mm Monoaxial Screw 40mm Magenta
• 00841732152120: 4.5mm Monoaxial Screw 35mm Magenta
• 00841732152113: 4.5mm Monoaxial Screw 30mm Magenta
• 00841732152106: 4.5mm Monoaxial Screw 25mm Magenta
• 00841732151819: 4.5mm Polyaxial Screw Reduction 45mm Magenta
• 00841732151802: 4.5mm Polyaxial Screw Reduction 40mm Magenta