Struxxure® Plate System

GUDID 00889929041413

Plate Set Screw Driver

NEXXT SPINE, LLC

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 00889929041413
• NIH Device Record Key: 9dcd9224-7cc3-4cfe-a1a6-52ea8dceb73d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Struxxure® Plate System
• Version Model Number: I63-32-02
• Company DUNS: 003489810
• Company Name: NEXXT SPINE, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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
• 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	00889929041413 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00889929041413]

Moist Heat or Steam Sterilization

[00889929041413]

Moist Heat or Steam Sterilization

[00889929041413]

Moist Heat or Steam Sterilization

[00889929041413]

Moist Heat or Steam Sterilization

[00889929041413]

Moist Heat or Steam Sterilization

[00889929041413]

Moist Heat or Steam Sterilization

[00889929041413]

Moist Heat or Steam Sterilization

[00889929041413]

Moist Heat or Steam Sterilization

[00889929041413]

Moist Heat or Steam Sterilization

[00889929041413]

Moist Heat or Steam Sterilization

[00889929041413]

Moist Heat or Steam Sterilization

[00889929041413]

Moist Heat or Steam Sterilization

[00889929041413]

Moist Heat or Steam Sterilization

[00889929041413]

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® Plate System]

• 00889929043066: Plate, Guided Drill
• 00889929043004: Inserter, Hex Inner Shaft
• 00889929042991: Lateral Plate Inserter
• 00889929042984: Lateral Construct Inserter
• 00889929042977: ALIF Plate Inserter
• 00889929042960: ALIF Construct Inserter
• 00889929042823: Lumbar Straight Driver, T20
• 00889929042816: Struxxure, Guided Angle Awl
• 00889929042809: Struxxure, Guided Straight Awl
• 00889929041413: Plate Set Screw Driver
• 00889929041406: Lateral Plate Lock Tool
• 00889929041024: Ø6.0mm Lumbar Screw, 60mm
• 00889929041017: Ø6.0mm Lumbar Screw, 55mm
• 00889929041000: Ø6.0mm Lumbar Screw, 50mm
• 00889929040997: Ø6.0mm Lumbar Screw, 45mm
• 00889929040980: Ø6.0mm Lumbar Screw, 40mm
• 00889929040973: Ø6.0mm Lumbar Screw, 35mm
• 00889929040966: Ø6.0mm Lumbar Screw, 30mm
• 00889929040959: Ø6.0mm Lumbar Screw, 25mm
• 00889929040942: Ø6.0mm Lumbar Screw, 20mm
• 00889929040935: Ø6.0mm Lumbar Screw, 15mm
• 00889929040928: Ø5.5mm Lumbar Screw, 60mm
• 00889929040911: Ø5.5mm Lumbar Screw, 55mm
• 00889929040904: Ø5.5mm Lumbar Screw, 50mm
• 00889929040898: Ø5.5mm Lumbar Screw, 45mm
• 00889929040881: Ø5.5mm Lumbar Screw, 40mm
• 00889929040874: Ø5.5mm Lumbar Screw, 35mm
• 00889929040867: Ø5.5mm Lumbar Screw, 30mm
• 00889929040850: Ø5.5mm Lumbar Screw, 25mm
• 00889929040843: Ø5.5mm Lumbar Screw, 20mm
• 00889929040836: Ø5.5mm Lumbar Screw, 15mm
• 00889929040645: ALIF Screw Caddy
• 00889929040638: Lateral Screw Caddy
• 00889929040614: ALIF Plate Caddy
• 00889929040607: Lateral Plate Caddy
• 00889929043059: Struxxure System Case
• 00889929045787: Struxxure, Guided Drill
• 00889929045770: Struxxure, Guided Angle Awl
• 00889929045763: Struxxure, Guided Straight Awl
• 00889929045855: Lumbar Straight Driver Sleeve
• 00889929058251: Struxxure Lumbar Screwdriver Inner
• 00889929058244: Struxxure Lumbar Screwdriver Outer