Monaco Pedicle Screw System

GUDID 00843210124414

Pre-Lordosed Rod, Monaco

Altus Spine, LLC

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system rod Bone-screw internal spinal fixation system rod Bone-screw internal spinal fixation system rod Bone-screw internal spinal fixation system rod Bone-screw internal spinal fixation system rod Bone-screw internal spinal fixation system rod Bone-screw internal spinal fixation system rod Bone-screw internal spinal fixation system rod Bone-screw internal spinal fixation system rod Bone-screw internal spinal fixation system rod Bone-screw internal spinal fixation system rod Bone-screw internal spinal fixation system rod Bone-screw internal spinal fixation system rod Bone-screw internal spinal fixation system rod

• Primary Device ID: 00843210124414
• NIH Device Record Key: df9998ec-dad8-4fc2-be75-c63d0a9b38dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monaco Pedicle Screw System
• Version Model Number: 922-6040
• 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

Device Dimensions

• Outer Diameter: 6 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 6 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843210124414 [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

[00843210124414]

Moist Heat or Steam Sterilization

[00843210124414]

Moist Heat or Steam Sterilization

[00843210124414]

Moist Heat or Steam Sterilization

[00843210124414]

Moist Heat or Steam Sterilization

[00843210124414]

Moist Heat or Steam Sterilization

[00843210124414]

Moist Heat or Steam Sterilization

[00843210124414]

Moist Heat or Steam Sterilization

[00843210124414]

Moist Heat or Steam Sterilization

[00843210124414]

Moist Heat or Steam Sterilization

[00843210124414]

Moist Heat or Steam Sterilization

[00843210124414]

Moist Heat or Steam Sterilization

[00843210124414]

Moist Heat or Steam Sterilization

[00843210124414]

Moist Heat or Steam Sterilization

[00843210124414]

Moist Heat or Steam Sterilization

[00843210124414]

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

On-Brand Devices [Monaco Pedicle Screw System]

• 00843210127019: External Hex Pre-Lordosed Rod, Monaco
• 00843210127002: External Hex Pre-Lordosed Rod, Monaco
• 00843210126999: External Hex Pre-Lordosed Rod, Monaco
• 00843210126982: External Hex Pre-Lordosed Rod, Monaco
• 00843210126975: External Hex Pre-Lordosed Rod, Monaco
• 00843210126968: External Hex Pre-Lordosed Rod, Monaco
• 00843210126951: External Hex Pre-Lordosed Rod, Monaco
• 00843210126944: External Hex Pre-Lordosed Rod, Monaco
• 00843210126937: External Hex Pre-Lordosed Rod, Monaco
• 00843210126920: External Hex Pre-Lordosed Rod, Monaco
• 00843210126913: External Hex Pre-Lordosed Rod, Monaco
• 00843210126906: External Hex Pre-Lordosed Rod, Monaco
• 00843210126890: External Hex Pre-Lordosed Rod, Monaco
• 00843210126883: External Hex Pre-Lordosed Rod, Monaco
• 00843210126876: External Hex Pre-Lordosed Rod, Monaco
• 00843210126869: External Hex Pre-Lordosed Rod, Monaco
• 00843210126852: External Hex Pre-Lordosed Rod, Monaco
• 00843210126845: External Hex Pre-Lordosed Rod, Monaco
• 00843210126838: External Hex Pre-Lordosed Rod, Monaco
• 00843210126821: External Hex Pre-Lordosed Rod, Monaco
• 00843210126814: External Hex Pre-Lordosed Rod, Monaco
• 00843210126807: External Hex Pre-Lordosed Rod, Monaco
• 00843210126791: External Hex Pre-Lordosed Rod, Monaco
• 00843210126784: External Hex Pre-Lordosed Rod, Monaco
• 00843210126777: Pre-Lordosed Rod, Monaco
• 00843210126760: Pre-Lordosed Rod, Monaco
• 00843210126753: Pre-Lordosed Rod, Monaco
• 00843210126746: Pre-Lordosed Rod, Monaco
• 00843210126739: Pre-Lordosed Rod, Monaco
• 00843210126722: Pre-Lordosed Rod, Monaco
• 00843210126715: Pre-Lordosed Rod, Monaco
• 00843210126708: Pre-Lordosed Rod, Monaco
• 00843210126692: Pre-Lordosed Rod, Monaco
• 00843210126685: Pre-Lordosed Rod, Monaco
• 00843210126678: Pre-Lordosed Rod, Monaco
• 00843210126661: Pre-Lordosed Rod, Monaco
• 00843210126654: Pre-Lordosed Rod, Monaco
• 00843210126647: Pre-Lordosed Rod, Monaco
• 00843210126630: Pre-Lordosed Rod, Monaco
• 00843210126623: Pre-Lordosed Rod, Monaco
• 00843210126616: Pre-Lordosed Rod, Monaco
• 00843210126609: Pre-Lordosed Rod, Monaco
• 00843210126593: Pre-Lordosed Rod, Monaco
• 00843210126586: Pre-Lordosed Rod, Monaco
• 00843210126579: Pre-Lordosed Rod, Monaco
• 00843210126562: Pre-Lordosed Rod, Monaco
• 00843210126555: Pre-Lordosed Rod, Monaco
• 00843210126548: Pre-Lordosed Rod, Monaco
• 00843210126531: Pre-Lordosed Rod, Monaco
• 00843210126524: Pre-Lordosed Rod, Monaco