Inertia® Pedicle Screw and Deformity Correxxion® System

GUDID 00889929059685

EXT Reduction Pedicle Screw, Ø6.5 x 60

NEXXT SPINE, LLC

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 00889929059685
• NIH Device Record Key: febeba04-e368-4fac-abf1-30cbbb82ecb1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inertia® Pedicle Screw and Deformity Correxxion® System
• Version Model Number: 10-69-6560
• Company DUNS: 003489810
• Company Name: NEXXT 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: 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: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com

Device Dimensions

• Outer Diameter: 6.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 60 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889929059685 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153453

FDA Product Code

• MNH: Orthosis, Spondylolisthesis Spinal Fixation

Sterilization

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

[00889929059685]

Moist Heat or Steam Sterilization

[00889929059685]

Moist Heat or Steam Sterilization

[00889929059685]

Moist Heat or Steam Sterilization

[00889929059685]

Moist Heat or Steam Sterilization

[00889929059685]

Moist Heat or Steam Sterilization

[00889929059685]

Moist Heat or Steam Sterilization

[00889929059685]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-25
• Device Publish Date: 2024-12-17

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