Struxxure®-L System

GUDID 00889929041208

Lateral, 2 Hole Plate, Size 18

NEXXT SPINE, LLC

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00889929041208
• NIH Device Record Key: 3b4fd6dc-4b42-43f2-9353-4a1390746b4e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Struxxure®-L System
• Version Model Number: 63-02-18
• 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
• 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
• 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

• Width: 17.25 Millimeter
• Length: 37.5 Millimeter
• Width: 17.25 Millimeter
• Length: 37.5 Millimeter
• Width: 17.25 Millimeter
• Length: 37.5 Millimeter
• Width: 17.25 Millimeter
• Length: 37.5 Millimeter
• Width: 17.25 Millimeter
• Length: 37.5 Millimeter
• Width: 17.25 Millimeter
• Length: 37.5 Millimeter
• Width: 17.25 Millimeter
• Length: 37.5 Millimeter
• Width: 17.25 Millimeter
• Length: 37.5 Millimeter
• Width: 17.25 Millimeter
• Length: 37.5 Millimeter
• Width: 17.25 Millimeter
• Length: 37.5 Millimeter
• Width: 17.25 Millimeter
• Length: 37.5 Millimeter
• Width: 17.25 Millimeter
• Length: 37.5 Millimeter
• Width: 17.25 Millimeter
• Length: 37.5 Millimeter
• Width: 17.25 Millimeter
• Length: 37.5 Millimeter
• Width: 17.25 Millimeter
• Length: 37.5 Millimeter
• Width: 17.25 Millimeter
• Length: 37.5 Millimeter
• Width: 17.25 Millimeter
• Length: 37.5 Millimeter
• Width: 17.25 Millimeter
• Length: 37.5 Millimeter
• Width: 17.25 Millimeter
• Length: 37.5 Millimeter
• Width: 17.25 Millimeter
• Length: 37.5 Millimeter
• Width: 17.25 Millimeter
• Length: 37.5 Millimeter
• Width: 17.25 Millimeter
• Length: 37.5 Millimeter
• Width: 17.25 Millimeter
• Length: 37.5 Millimeter
• Width: 17.25 Millimeter
• Length: 37.5 Millimeter
• Width: 17.25 Millimeter
• Length: 37.5 Millimeter
• Width: 17.25 Millimeter
• Length: 37.5 Millimeter
• Width: 17.25 Millimeter
• Length: 37.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889929041208 [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

[00889929041208]

Moist Heat or Steam Sterilization

[00889929041208]

Moist Heat or Steam Sterilization

[00889929041208]

Moist Heat or Steam Sterilization

[00889929041208]

Moist Heat or Steam Sterilization

[00889929041208]

Moist Heat or Steam Sterilization

[00889929041208]

Moist Heat or Steam Sterilization

[00889929041208]

Moist Heat or Steam Sterilization

[00889929041208]

Moist Heat or Steam Sterilization

[00889929041208]

Moist Heat or Steam Sterilization

[00889929041208]

Moist Heat or Steam Sterilization

[00889929041208]

Moist Heat or Steam Sterilization

[00889929041208]

Moist Heat or Steam Sterilization

[00889929041208]

Moist Heat or Steam Sterilization

[00889929041208]

Moist Heat or Steam Sterilization

[00889929041208]

Moist Heat or Steam Sterilization

[00889929041208]

Moist Heat or Steam Sterilization

[00889929041208]

Moist Heat or Steam Sterilization

[00889929041208]

Moist Heat or Steam Sterilization

[00889929041208]

Moist Heat or Steam Sterilization

[00889929041208]

Moist Heat or Steam Sterilization

[00889929041208]

Moist Heat or Steam Sterilization

[00889929041208]

Moist Heat or Steam Sterilization

[00889929041208]

Moist Heat or Steam Sterilization

[00889929041208]

Moist Heat or Steam Sterilization

[00889929041208]

Moist Heat or Steam Sterilization

[00889929041208]

Moist Heat or Steam Sterilization

[00889929041208]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-08
• Device Publish Date: 2020-12-31

On-Brand Devices [Struxxure®-L System]

• 00889929042854: Lateral Plate Set Screw
• 00889929041215: Lateral, 2 Hole Plate, Size 20
• 00889929041208: Lateral, 2 Hole Plate, Size 18
• 00889929041192: Lateral, 2 Hole Plate, Size 16
• 00889929041185: Lateral, 2 Hole Plate, Size 14
• 00889929041178: Lateral, 2 Hole Plate, Size 12
• 00889929041161: Lateral, 2 Hole Plate, Size 10
• 00889929041154: Lateral, 2 Hole Plate, Size 8
• 00889929053010: Struxxure Lumbar Slap Hammer Adapter