Struxxure®-A System

GUDID 00889929055946

Struxxure-A Plate System Case

NEXXT SPINE, LLC

Device sterilization/disinfection container, reusable

• Primary Device ID: 00889929055946
• NIH Device Record Key: 539dbc49-5383-4418-a948-a8a75366a072
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Struxxure®-A System
• Version Model Number: C63-01-01A
• 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: false
• Lot Batch: false
• Serial Number: true
• 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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00889929055946 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202192

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[00889929055946]

Moist Heat or Steam Sterilization

[00889929055946]

Moist Heat or Steam Sterilization

[00889929055946]

Moist Heat or Steam Sterilization

[00889929055946]

Moist Heat or Steam Sterilization

[00889929055946]

Moist Heat or Steam Sterilization

[00889929055946]

Moist Heat or Steam Sterilization

[00889929055946]

Moist Heat or Steam Sterilization

[00889929055946]

Moist Heat or Steam Sterilization

[00889929055946]

Moist Heat or Steam Sterilization

[00889929055946]

Moist Heat or Steam Sterilization

[00889929055946]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-30
• Device Publish Date: 2024-04-22

On-Brand Devices [Struxxure®-A System]

• 00889929041284: ALIF, 4 Hole Plate, Size 20
• 00889929041277: ALIF, 4 Hole Plate, Size 18
• 00889929041260: ALIF, 4 Hole Plate, Size 16
• 00889929041253: ALIF, 4 Hole Plate, Size 14
• 00889929041246: ALIF, 4 Hole Plate, Size 12
• 00889929041239: ALIF, 4 Hole Plate, Size 10
• 00889929041222: ALIF, 4 Hole Plate, Size 8
• 00889929055946: Struxxure-A Plate System Case