Struxxure® Anterior Cervical Plate System

GUDID 00889929008546

AC Plate, 2 Level, 50mm

NEXXT SPINE, LLC

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00889929008546
• NIH Device Record Key: 696edf39-f21a-4c3d-a28e-dc385c0da8b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Struxxure® Anterior Cervical Plate System
• Version Model Number: 31-2-50
• 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: false
• 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
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com

Device Dimensions

• Length: 50 Millimeter
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889929008546 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133475

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[00889929008546]

Moist Heat or Steam Sterilization

[00889929008546]

Moist Heat or Steam Sterilization

[00889929008546]

Moist Heat or Steam Sterilization

[00889929008546]

Moist Heat or Steam Sterilization

[00889929008546]

Moist Heat or Steam Sterilization

[00889929008546]

Moist Heat or Steam Sterilization

[00889929008546]

Moist Heat or Steam Sterilization

[00889929008546]

Moist Heat or Steam Sterilization

[00889929008546]

Moist Heat or Steam Sterilization

[00889929008546]

Moist Heat or Steam Sterilization

[00889929008546]

Moist Heat or Steam Sterilization

[00889929008546]

Moist Heat or Steam Sterilization

[00889929008546]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-09-18
• Device Publish Date: 2015-07-30

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

• 00889929041703: Struxxure, Corpectomy Plate and Screw Caddy
• 00889929050279: Struxxure, Corpectomy Plate and Screw Caddy
• 00889929009826: Fixed Screw, Self-Tap, Ø4.35x15 mm
• 00889929009819: Fixed Screw, Self-Tap, Ø4.35x13 mm
• 00889929009802: Variable Screw, Self-Tap, Ø4.35x15 mm
• 00889929009796: Variable Screw, Self-Tap, Ø4.35x13 mm
• 00889929009789: Fixed Screw, Self-Drill, Ø4.35x15 mm
• 00889929009772: Fixed Screw, Self-Drill, Ø4.35x13 mm
• 00889929009765: Fixed Screw, Self-Drill, Ø4.0x15 mm
• 00889929009758: Fixed Screw, Self-Drill, Ø4.0x13 mm
• 00889929009741: Variable Screw, Self-Drill, Ø4.35x15 mm
• 00889929009734: Variable Screw, Self-Drill, Ø4.35x13 mm
• 00889929009512: Fixed Screw, Self-Tap, Ø4.35x20 mm
• 00889929009505: Fixed Screw, Self-Tap, Ø4.35x18 mm
• 00889929009499: Fixed Screw, Self-Tap, Ø4.35x16 mm
• 00889929009482: Fixed Screw, Self-Tap, Ø4.35x14 mm
• 00889929009475: Fixed Screw, Self-Tap, Ø4.35x12 mm
• 00889929009468: Fixed Screw, Self-Tap, Ø4.35x10 mm
• 00889929009451: Fixed Screw, Self-Tap, Ø4.0x20 mm
• 00889929009444: Fixed Screw, Self-Tap, Ø4.0x18 mm
• 00889929009437: Fixed Screw, Self-Tap, Ø4.0x16 mm
• 00889929009420: Fixed Screw, Self-Tap, Ø4.0x14 mm
• 00889929009413: Fixed Screw, Self-Tap, Ø4.0x12 mm
• 00889929009406: Fixed Screw, Self-Tap, Ø4.0x10 mm
• 00889929009390: Variable Screw, Self-Tap, Ø4.35x20 mm
• 00889929009383: Variable Screw, Self-Tap, Ø4.35x18 mm
• 00889929009376: Variable Screw, Self-Tap, Ø4.35x16 mm
• 00889929009369: Variable Screw, Self-Tap, Ø4.35x14 mm
• 00889929009352: Variable Screw, Self-Tap, Ø4.35x12 mm
• 00889929009345: Variable Screw, Self-Tap, Ø4.35x10 mm
• 00889929009338: Variable Screw, Self-Tap, Ø4.0x20 mm
• 00889929009321: Variable Screw, Self-Tap, Ø4.0x19 mm
• 00889929009314: Variable Screw, Self-Tap, Ø4.0x18 mm
• 00889929009307: Variable Screw, Self-Tap, Ø4.0x17 mm
• 00889929009291: Variable Screw, Self-Tap, Ø4.0x16 mm
• 00889929009284: Variable Screw, Self-Tap, Ø4.0x15 mm
• 00889929009277: Variable Screw, Self-Tap, Ø4.0x14 mm
• 00889929009260: Variable Screw, Self-Tap, Ø4.0x13 mm
• 00889929009253: Variable Screw, Self-Tap, Ø4.0x12 mm
• 00889929009246: Variable Screw, Self-Tap, Ø4.0x11 mm
• 00889929009239: Variable Screw, Self-Tap, Ø4.0x10 mm
• 00889929009222: Fixed Screw, Self-Drill, Ø4.35x20 mm
• 00889929009215: Fixed Screw, Self-Drill, Ø4.35x18 mm
• 00889929009208: Fixed Screw, Self-Drill, Ø4.35x16 mm
• 00889929009192: Fixed Screw, Self-Drill, Ø4.35x14 mm
• 00889929009185: Fixed Screw, Self-Drill, Ø4.35x12 mm
• 00889929009178: Fixed Screw, Self-Drill, Ø4.35x10 mm
• 00889929009161: Fixed Screw, Self-Drill, Ø4.0x20 mm
• 00889929009154: Fixed Screw, Self-Drill, Ø4.0x18 mm
• 00889929009147: Fixed Screw, Self-Drill, Ø4.0x16 mm