NEXXT MATRIXX® Stand Alone Cervical-TL System

GUDID 00889929044919

SA Cervical-TL, Zero Profile Inserter

NEXXT SPINE, LLC

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 00889929044919
• NIH Device Record Key: 4a3c602f-4544-4095-bd38-871fc59ab0c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NEXXT MATRIXX® Stand Alone Cervical-TL System
• Version Model Number: I52N-01-04
• 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
• 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	00889929044919 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200543

FDA Product Code

• OVE: Intervertebral Fusion Device With Integrated Fixation, Cervical

Sterilization

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

[00889929044919]

Moist Heat or Steam Sterilization

[00889929044919]

Moist Heat or Steam Sterilization

[00889929044919]

Moist Heat or Steam Sterilization

[00889929044919]

Moist Heat or Steam Sterilization

[00889929044919]

Moist Heat or Steam Sterilization

[00889929044919]

Moist Heat or Steam Sterilization

[00889929044919]

Moist Heat or Steam Sterilization

[00889929044919]

Moist Heat or Steam Sterilization

[00889929044919]

Moist Heat or Steam Sterilization

[00889929044919]

Moist Heat or Steam Sterilization

[00889929044919]

Moist Heat or Steam Sterilization

[00889929044919]

Moist Heat or Steam Sterilization

[00889929044919]

Moist Heat or Steam Sterilization

[00889929044919]

Moist Heat or Steam Sterilization

[00889929044919]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-27
• Device Publish Date: 2021-04-19

On-Brand Devices [NEXXT MATRIXX® Stand Alone Cervical-TL System]

• 00889929036211: SA Cervical-TL, DTS Guide Head Caddy
• 00889929036204: SA Cervical-TL, Trial, 12x15x12mm
• 00889929036198: SA Cervical-TL, Trial, 12x15x11mm
• 00889929036181: SA Cervical-TL, Trial, 12x15x10mm
• 00889929036174: SA Cervical-TL, Trial, 12x15x9mm
• 00889929036167: SA Cervical-TL, Trial, 12x15x8mm
• 00889929036150: SA Cervical-TL, Trial, 12x15x7mm
• 00889929036143: SA Cervical-TL, Trial, 12x15x6mm
• 00889929036136: SA Cervical-TL, Trial, 12x15x5mm
• 00889929036129: SA Cervical-TL, Lock Tool
• 00889929036112: SA Cervical-TL, Guide, 12H
• 00889929036105: SA Cervical-TL, Guide, 11H
• 00889929036099: SA Cervical-TL, Guide, 10H
• 00889929036082: SA Cervical-TL, Guide, 9H
• 00889929036075: SA Cervical-TL, Guide, 8H
• 00889929036068: SA Cervical-TL, Guide, 7H
• 00889929036051: SA Cervical-TL, Guide, 6H
• 00889929036044: SA Cervical-TL, Guide, 5H
• 00889929036037: SA Cervical-TL, Modular Inserter
• 00889929036020: SA Cervical-TL, Fixed Inserter
• 00889929036013: SA Cervical-TL, Straight Drill
• 00889929036006: SA Cervical-TL, Straight Screw Inserter
• 00889929035993: Sleeved Awl
• 00889929035573: SA Cervical-TL, 16Dx18Wx12H
• 00889929035566: SA Cervical-TL, 16Dx18Wx11H
• 00889929035559: SA Cervical-TL, 16Dx18Wx10H
• 00889929035542: SA Cervical-TL, 16Dx18Wx9H
• 00889929035535: SA Cervical-TL, 16Dx18Wx8H
• 00889929035528: SA Cervical-TL, 16Dx18Wx7H
• 00889929035511: SA Cervical-TL, 16Dx18Wx6H
• 00889929035504: SA Cervical-TL, 16Dx18Wx5H
• 00889929035498: SA Cervical-TL, 14Dx16Wx12H
• 00889929035481: SA Cervical-TL, 14Dx16Wx11H
• 00889929035474: SA Cervical-TL, 14Dx16Wx10H
• 00889929035467: SA Cervical-TL, 14Dx16Wx9H
• 00889929035450: SA Cervical-TL, 14Dx16Wx8H
• 00889929035443: SA Cervical-TL, 14Dx16Wx7H
• 00889929035436: SA Cervical-TL, 14Dx16Wx6H
• 00889929035429: SA Cervical-TL, 14Dx16Wx5H
• 00889929035412: SA Cervical-TL, 12Dx15Wx12H
• 00889929035405: SA Cervical-TL, 12Dx15Wx11H
• 00889929035399: SA Cervical-TL, 12Dx15Wx10H
• 00889929035382: SA Cervical-TL, 12Dx15Wx9H
• 00889929035375: SA Cervical-TL, 12Dx15Wx8H
• 00889929035368: SA Cervical-TL, 12Dx15Wx7H
• 00889929035351: SA Cervical-TL, 12Dx15Wx6H
• 00889929035344: SA Cervical-TL, 12Dx15Wx5H
• 00889929035337: SA Cervical-TL, Ø4.0x18mm Screw
• 00889929035320: SA Cervical-TL, Ø4.0x16mm Screw
• 00889929035313: SA Cervical-TL, Ø4.0x14mm Screw