Fuse Pedicle Screw System FZ-MN8080CA

GUDID B565FZMN8080CA1

Polyaxial Reduction Tab Screw 8.0 x 80 mm Cannulated

CPM MEDICAL CONSULTANTS, LLC

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: B565FZMN8080CA1
• NIH Device Record Key: f682caf7-14b5-4f02-8070-c192b7d91ed9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fuse Pedicle Screw System
• Version Model Number: Rev D
• Catalog Number: FZ-MN8080CA
• Company DUNS: 017138000
• Company Name: CPM MEDICAL CONSULTANTS, LLC
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx

Device Dimensions

• Outer Diameter: 8 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 80 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B565FZMN8080CA1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182283

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[B565FZMN8080CA1]

Moist Heat or Steam Sterilization

[B565FZMN8080CA1]

Moist Heat or Steam Sterilization

[B565FZMN8080CA1]

Moist Heat or Steam Sterilization

[B565FZMN8080CA1]

Moist Heat or Steam Sterilization

[B565FZMN8080CA1]

Moist Heat or Steam Sterilization

[B565FZMN8080CA1]

Moist Heat or Steam Sterilization

[B565FZMN8080CA1]

Moist Heat or Steam Sterilization

[B565FZMN8080CA1]

Moist Heat or Steam Sterilization

[B565FZMN8080CA1]

Moist Heat or Steam Sterilization

[B565FZMN8080CA1]

Moist Heat or Steam Sterilization

[B565FZMN8080CA1]

Moist Heat or Steam Sterilization

[B565FZMN8080CA1]

Moist Heat or Steam Sterilization

[B565FZMN8080CA1]

Moist Heat or Steam Sterilization

[B565FZMN8080CA1]

Moist Heat or Steam Sterilization

[B565FZMN8080CA1]

Moist Heat or Steam Sterilization

[B565FZMN8080CA1]

Moist Heat or Steam Sterilization

[B565FZMN8080CA1]

Moist Heat or Steam Sterilization

[B565FZMN8080CA1]

Moist Heat or Steam Sterilization

[B565FZMN8080CA1]

Moist Heat or Steam Sterilization

[B565FZMN8080CA1]

Moist Heat or Steam Sterilization

[B565FZMN8080CA1]

Moist Heat or Steam Sterilization

[B565FZMN8080CA1]

Moist Heat or Steam Sterilization

[B565FZMN8080CA1]

Moist Heat or Steam Sterilization

[B565FZMN8080CA1]

Moist Heat or Steam Sterilization

[B565FZMN8080CA1]

Moist Heat or Steam Sterilization

[B565FZMN8080CA1]

Moist Heat or Steam Sterilization

[B565FZMN8080CA1]

Moist Heat or Steam Sterilization

[B565FZMN8080CA1]

Moist Heat or Steam Sterilization

[B565FZMN8080CA1]

Moist Heat or Steam Sterilization

[B565FZMN8080CA1]

Moist Heat or Steam Sterilization

[B565FZMN8080CA1]

Moist Heat or Steam Sterilization

[B565FZMN8080CA1]

Moist Heat or Steam Sterilization

[B565FZMN8080CA1]

Moist Heat or Steam Sterilization

[B565FZMN8080CA1]

Moist Heat or Steam Sterilization

[B565FZMN8080CA1]

Moist Heat or Steam Sterilization

[B565FZMN8080CA1]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-27
• Device Publish Date: 2020-07-17

On-Brand Devices [Fuse Pedicle Screw System]

• B565FZTC6555CA1: 6.5 mm x 55 mm Tall Cannulated Polyaxial Pedicle Screw
• B565FZTC6550CA1: 6.5 mm x 50 mm Tall Cannulated Polyaxial Pedicle Screw
• B565FZTC6545CA1: 6.5 mm x 45 mm Tall Cannulated Polyaxial Pedicle Screw
• B565FZTC6540CA1: 6.5 mm x 40 mm Tall Cannulated Polyaxial Pedicle Screw
• B565FZTC6535CA1: 6.5 mm x 35 mm Tall Cannulated Polyaxial Pedicle Screw
• B565FZTC6530CA1: 6.5 mm x 30 mm Tall Cannulated Polyaxial Pedicle Screw
• B565FZTC5550CA1: 5.5 mm x 50 mm Tall Cannulated Polyaxial Pedicle Screw
• B565FZTC5545CA1: 5.5 mm x 45 mm Tall Cannulated Polyaxial Pedicle Screw
• B565FZTC5540CA1: 5.5 mm x 40 mm Tall Cannulated Polyaxial Pedicle Screw
• B565FZTC5535CA1: 5.5 mm x 35 mm Tall Cannulated Polyaxial Pedicle Screw
• B565FZSC1001: Set Caps
• B565FZMN7555A1: 7.5mm x 55mm MID TOP Screw Non-Cannulated
• B565FZMN7550A1: 7.5mm x 50mm MID TOP Screw Non-Cannulated
• B565FZMN7545A1: 7.5mm x 45mm MID TOP Screw Non-Cannulated
• B565FZMN7540A1: 7.5mm x 40mm MID TOP Screw Non-Cannulated
• B565FZMN7535A1: 7.5mm x 35mm MID TOP Screw Non-Cannulated
• B565FZMN7530A1: 7.5mm x 30mm MID TOP Screw Non-Cannulated
• B565FZMN6555A1: 6.5mm x 55mm MID TOP Screw Non-Cannulated
• B565FZMN6550A1: 6.5mm x 50mm MID TOP Screw Non-Cannulated
• B565FZMN6545A1: 6.5 mm x 45 mm MID TOP Screw Non-Cannulated
• B565FZMN6540A1: 6.5 mm x 40 mm MID TOP Screw Non-Cannulated
• B565FZMN6535A1: 6.5 mm x 35 mm MID TOP Screw Non-Cannulated
• B565FZMN6530A1: 6.5 mm x 30 mm MID TOP Screw Non-Cannulated
• B565FZMN5550A1: 5.5 mm x 50 mm MID TOP Screw Non-Cannulated
• B565FZMN5545A1: 5.5 mm x 45 mm MID TOP Screw Non-Cannulated
• B565FZMN5540A1: 5.5 mm x 40 mm MID TOP Screw Non-Cannulated
• B565FZMN5535A1: 5.5 mm x 35 mm MID TOP Screw Non-Cannulated
• B565FZMN5530A1: 5.5 mm x 30 mm MID TOP Screw Non-Cannulated
• B565FZMN5525A1: 5.5 mm x 25 mm MID TOP Screw Non-Cannulated
• B565FZMC55951: 5.5 mm x 95 mm MIS Curved Rod
• B565FZMC55901: 5.5 mm x 90 mm MIS Curved Rod
• B565FZMC55851: 5.5 mm x 85 mm MIS Curved Rod
• B565FZMC55801: 5.5 mm x 80 mm MIS Curved Rod
• B565FZMC55751: 5.5 mm x 75 mm MIS Curved Rod
• B565FZMC55701: 5.5 mm x 70 mm MIS Curved Rod
• B565FZMC55651: 5.5 mm x 65 mm MIS Curved Rod
• B565FZMC55601: 5.5 mm x 60 mm MIS Curved Rod
• B565FZMC55551: 5.5 mm x 55 mm MIS Curved Rod
• B565FZMC55501: 5.5 mm x 50 mm MIS Curved Rod
• B565FZMC55451: 5.5 mm x 45 mm MIS Curved Rod
• B565FZMC55401: 5.5 mm x 40 mm MIS Curved Rod
• B565FZMC551501: 5.5 mm x 150 mm MIS Curved Rod
• B565FZMC551401: 5.5 mm x 140 mm MIS Curved Rod
• B565FZMC551301: 5.5 mm x 130 mm MIS Curved Rod
• B565FZMC551201: 5.5 mm x 120 mm MIS Curved Rod
• B565FZMC551101: 5.5 mm x 110 mm MIS Curved Rod
• B565FZMC551001: 5.5 mm x 100 mm MIS Curved Rod
• B565FZLN7555CA1: 7.5 mm x 55 mm Low-Top Polyaxial Pedicle Screw Cannulated
• B565FZLN7550CA1: 7.5 mm x 50 mm Low-Top Polyaxial Pedicle Screw Cannulated
• B565FZLN7545CA1: 7.5 mm x 45 mm Low-Top Polyaxial Pedicle Screw Cannulated