Struxxure® MCS Anterior Cervical System

GUDID 00889929055274

4-Hole Plate Caddy

NEXXT SPINE, LLC

Device sterilization/disinfection container, reusable

• Primary Device ID: 00889929055274
• NIH Device Record Key: 1e6b1577-5659-44dc-bdf5-22ff4e26e01f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Struxxure® MCS Anterior Cervical System
• Version Model Number: C33-02-04
• 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: 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
• 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	00889929055274 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240690

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[00889929055274]

Moist Heat or Steam Sterilization

[00889929055274]

Moist Heat or Steam Sterilization

[00889929055274]

Moist Heat or Steam Sterilization

[00889929055274]

Moist Heat or Steam Sterilization

[00889929055274]

Moist Heat or Steam Sterilization

[00889929055274]

Moist Heat or Steam Sterilization

[00889929055274]

Moist Heat or Steam Sterilization

[00889929055274]

Moist Heat or Steam Sterilization

[00889929055274]

Moist Heat or Steam Sterilization

[00889929055274]

Moist Heat or Steam Sterilization

[00889929055274]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-29
• Device Publish Date: 2024-04-20

On-Brand Devices [Struxxure® MCS Anterior Cervical System]

• 00889929055762: 4-Hole Plate, Size 12
• 00889929055755: 4-Hole Plate, Size 11
• 00889929055748: 3-Hole Plate, Size 12
• 00889929055731: 3-Hole Plate, Size 11
• 00889929055724: 2-Hole Plate, Size 12
• 00889929055717: 2-Hole Plate, Size 11
• 00889929055564: Punch Awl
• 00889929055557: Plate Inserter
• 00889929055540: Construct Inserter Post
• 00889929055533: Construct Inserter
• 00889929055304: 4-Hole Plate Loading Block
• 00889929055298: 3-Hole Plate Loading Block
• 00889929055281: 2-Hole Plate Loading Block
• 00889929055274: 4-Hole Plate Caddy
• 00889929055267: 3-Hole Plate Caddy
• 00889929055250: 2-Hole Plate Caddy
• 00889929055199: 4-Hole Plate, Size 10
• 00889929055182: 4-Hole Plate, Size 9
• 00889929055175: 4-Hole Plate, Size 8
• 00889929055168: 4-Hole Plate, Size 7
• 00889929055151: 4-Hole Plate, Size 6
• 00889929055144: 4-Hole Plate, Size 5
• 00889929055137: 3-Hole Plate, Size 10
• 00889929055120: 3-Hole Plate, Size 9
• 00889929055113: 3-Hole Plate, Size 8
• 00889929055106: 3-Hole Plate, Size 7
• 00889929055090: 3-Hole Plate, Size 6
• 00889929055083: 3-Hole Plate, Size 5
• 00889929055076: 2-Hole Plate, Size 10
• 00889929055069: 2-Hole Plate, Size 9
• 00889929055052: 2-Hole Plate, Size 8
• 00889929055045: 2-Hole Plate, Size 7
• 00889929055038: 2-Hole Plate, Size 6
• 00889929055021: 2-Hole Plate, Size 5
• 00889929056509: Struxxure MCS General Case
• 00889929055960: Struxxure MCS Case
• 00889929057971: Construct Inserter Post - Small
• 00889929059067: Struxxure MCS 2mm Tamp