Monaco Uni-Planar

GUDID 00843210150949

Pedicle Screw, 5.5mm x 25mm

Altus Spine, LLC

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00843210150949
• NIH Device Record Key: cb240ba0-c515-482b-b61e-53ce362936e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monaco Uni-Planar
• Version Model Number: 813-5525
• 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: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843210150949 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211027

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[00843210150949]

Moist Heat or Steam Sterilization

[00843210150949]

Moist Heat or Steam Sterilization

[00843210150949]

Moist Heat or Steam Sterilization

[00843210150949]

Moist Heat or Steam Sterilization

[00843210150949]

Moist Heat or Steam Sterilization

[00843210150949]

Moist Heat or Steam Sterilization

[00843210150949]

Moist Heat or Steam Sterilization

[00843210150949]

Moist Heat or Steam Sterilization

[00843210150949]

Moist Heat or Steam Sterilization

[00843210150949]

Moist Heat or Steam Sterilization

[00843210150949]

Moist Heat or Steam Sterilization

[00843210150949]

Moist Heat or Steam Sterilization

[00843210150949]

Moist Heat or Steam Sterilization

[00843210150949]

Moist Heat or Steam Sterilization

[00843210150949]

Moist Heat or Steam Sterilization

[00843210150949]

Moist Heat or Steam Sterilization

[00843210150949]

Moist Heat or Steam Sterilization

[00843210150949]

Moist Heat or Steam Sterilization

[00843210150949]

Moist Heat or Steam Sterilization

[00843210150949]

Moist Heat or Steam Sterilization

[00843210150949]

Moist Heat or Steam Sterilization

[00843210150949]

Moist Heat or Steam Sterilization

[00843210150949]

Moist Heat or Steam Sterilization

[00843210150949]

Moist Heat or Steam Sterilization

[00843210150949]

Moist Heat or Steam Sterilization

[00843210150949]

Moist Heat or Steam Sterilization

[00843210150949]

Moist Heat or Steam Sterilization

[00843210150949]

Moist Heat or Steam Sterilization

[00843210150949]

Moist Heat or Steam Sterilization

[00843210150949]

Moist Heat or Steam Sterilization

[00843210150949]

Moist Heat or Steam Sterilization

[00843210150949]

Moist Heat or Steam Sterilization

[00843210150949]

Moist Heat or Steam Sterilization

[00843210150949]

Moist Heat or Steam Sterilization

[00843210150949]

Moist Heat or Steam Sterilization

[00843210150949]

Moist Heat or Steam Sterilization

[00843210150949]

Moist Heat or Steam Sterilization

[00843210150949]

Moist Heat or Steam Sterilization

[00843210150949]

Moist Heat or Steam Sterilization

[00843210150949]

Moist Heat or Steam Sterilization

[00843210150949]

Moist Heat or Steam Sterilization

[00843210150949]

Moist Heat or Steam Sterilization

[00843210150949]

Moist Heat or Steam Sterilization

[00843210150949]

Moist Heat or Steam Sterilization

[00843210150949]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-27
• Device Publish Date: 2023-12-19

On-Brand Devices [Monaco Uni-Planar]

• 00843210170046: Pedicle Screw, 9.5mm x 120mm
• 00843210170039: Pedicle Screw, 9.5mm x 110mm
• 00843210170022: Pedicle Screw, 9.5mm x 100mm
• 00843210170015: Pedicle Screw, 9.5mm x 90mm
• 00843210170008: Pedicle Screw, 9.5mm x 80mm
• 00843210169996: Pedicle Screw, 9.5mm x 70mm
• 00843210169989: Pedicle Screw, 9.5mm x 60mm
• 00843210169972: Pedicle Screw, 9.5mm x 55mm
• 00843210169965: Pedicle Screw, 9.5mm x 50mm
• 00843210151014: Pedicle Screw, 5.5mm x 60mm
• 00843210151007: Pedicle Screw, 5.5mm x 55mm
• 00843210150994: Pedicle Screw, 5.5mm x 50mm
• 00843210150987: Pedicle Screw, 5.5mm x 45mm
• 00843210150970: Pedicle Screw, 5.5mm x 40mm
• 00843210150963: Pedicle Screw, 5.5mm x 35mm
• 00843210150956: Pedicle Screw, 5.5mm x 30mm
• 00843210150949: Pedicle Screw, 5.5mm x 25mm
• 00843210150932: Pedicle Screw, 4.5mm x 60mm
• 00843210150925: Pedicle Screw, 4.5mm x 55mm
• 00843210150918: Pedicle Screw, 4.5mm x 50mm
• 00843210150901: Pedicle Screw, 4.5mm x 45mm
• 00843210150895: Pedicle Screw, 4.5mm x 40mm
• 00843210150888: Pedicle Screw, 4.5mm x 35mm
• 00843210150871: Pedicle Screw, 4.5mm x 30mm
• 00843210150864: Pedicle Screw, 4.5mm x 25mm
• 00843210169811: Pedicle Screw, 8.5mm x 45mm
• 00843210169804: Pedicle Screw, 85mm x 40mm
• 00843210169798: Pedicle Screw, 85mm x 35mm
• 00843210169781: Pedicle Screw, 8.5mm x 30mm
• 00843210169774: Pedicle Screw, 8.5mm x 25mm
• 00843210169767: Pedicle Screw, 7.5mm x 120mm
• 00843210169750: Pedicle Screw, 7.5mm x 110mm
• 00843210169743: Pedicle Screw, 7.5mm x 100mm
• 00843210169736: Pedicle Screw, 7.5mm x 90mm
• 00843210169729: Pedicle Screw, 7.5mm x 80mm
• 00843210169712: Pedicle Screw, 7.5mm x 70mm
• 00843210169705: Pedicle Screw, 7.5mm x 60mm
• 00843210169699: Pedicle Screw, 7.5mm x 55mm
• 00843210169682: Pedicle Screw,7.5mm x 50mm
• 00843210169675: Pedicle Screw, 7.5mm x 45mm
• 00843210169668: Pedicle Screw, 7.5mm x 40mm
• 00843210169651: Pedicle Screw, 7.5mm x 35mm
• 00843210169644: Pedicle Screw, 7.5mm x 30mm
• 00843210169637: Pedicle Screw, 7.5mm x 25mm
• 00843210151151: Pedicle Screw,6.5mm x 120mm
• 00843210151144: Pedicle Screw, 6.5mm x 110mm
• 00843210151137: Pedicle Screw, 6.5mm x 100mm
• 00843210151120: Pedicle Screw, 6.5mm x 90mm
• 00843210151113: Pedicle Screw, 6.5mm x 80mm
• 00843210151106: Pedicle Screw, 6.5mm x 70mm