Monaco Pedicle Screw System

GUDID 00843210124582

External Hex Straight Rod, Monaco

Altus Spine, LLC

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00843210124582
• NIH Device Record Key: 5f31ce4e-21bf-4506-9005-3417cb42c33e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monaco Pedicle Screw System
• Version Model Number: 911-5040
• Company DUNS: 078331322
• Company Name: Altus Spine, 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: 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(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com

Device Dimensions

• Length: 40 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 40 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843210124582 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181339

FDA Product Code

• KWQ: Appliance, fixation, spinal intervertebral body

Sterilization

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

[00843210124582]

Moist Heat or Steam Sterilization

[00843210124582]

Moist Heat or Steam Sterilization

[00843210124582]

Moist Heat or Steam Sterilization

[00843210124582]

Moist Heat or Steam Sterilization

[00843210124582]

Moist Heat or Steam Sterilization

[00843210124582]

Moist Heat or Steam Sterilization

[00843210124582]

Moist Heat or Steam Sterilization

[00843210124582]

Moist Heat or Steam Sterilization

[00843210124582]

Moist Heat or Steam Sterilization

[00843210124582]

Moist Heat or Steam Sterilization

[00843210124582]

Moist Heat or Steam Sterilization

[00843210124582]

Moist Heat or Steam Sterilization

[00843210124582]

Moist Heat or Steam Sterilization

[00843210124582]

Moist Heat or Steam Sterilization

[00843210124582]

Moist Heat or Steam Sterilization

[00843210124582]

Moist Heat or Steam Sterilization

[00843210124582]

Moist Heat or Steam Sterilization

[00843210124582]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-11-02
• Device Publish Date: 2018-10-02

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