NEXXT MATRIXX® Stand Alone ALIF System

GUDID 00889929044971

SA ALIF Trial, 30Dx40Wx8H, 14°

NEXXT SPINE, LLC

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 00889929044971
• NIH Device Record Key: 7022e159-7df3-48e4-8ba9-eb3b69960083
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NEXXT MATRIXX® Stand Alone ALIF System
• Version Model Number: I61-TR3040-08-14
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889929044971 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202230

FDA Product Code

• OVD: Intervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

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

[00889929044971]

Moist Heat or Steam Sterilization

[00889929044971]

Moist Heat or Steam Sterilization

[00889929044971]

Moist Heat or Steam Sterilization

[00889929044971]

Moist Heat or Steam Sterilization

[00889929044971]

Moist Heat or Steam Sterilization

[00889929044971]

Moist Heat or Steam Sterilization

[00889929044971]

Moist Heat or Steam Sterilization

[00889929044971]

Moist Heat or Steam Sterilization

[00889929044971]

Moist Heat or Steam Sterilization

[00889929044971]

Moist Heat or Steam Sterilization

[00889929044971]

Moist Heat or Steam Sterilization

[00889929044971]

Moist Heat or Steam Sterilization

[00889929044971]

Moist Heat or Steam Sterilization

[00889929044971]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-04
• Device Publish Date: 2021-04-26

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

• 00889929043073: SA ALIF, Implant Remover
• 00889929044230: SA ALIF Fixed Angle Driver
• 00889929044056: SA ALIF 25° Trial Caddy
• 00889929044049: SA ALIF 30Dx40W Trial Caddy
• 00889929044032: SA ALIF 27Dx36W Trial Caddy
• 00889929044025: SA ALIF 24Dx32W Trial Caddy
• 00889929043929: SA ALIF, Poly Awl
• 00889929043912: SA ALIF, Guided Drill
• 00889929043905: SA ALIF, Guided Angle Awl
• 00889929043899: SA ALIF, Guided Straight Awl
• 00889929043882: SA ALIF, Single Barrel Awl Guide
• 00889929043875: Annulotomy Template, 40mm
• 00889929043868: Annulotomy Template, 36mm
• 00889929043851: Annulotomy Template, 32mm
• 00889929043844: Annulotomy Centering Pin
• 00889929043837: SA ALIF Trial, 30Dx40Wx20H, 25°
• 00889929043820: SA ALIF Trial, 30Dx40Wx18H, 25°
• 00889929043813: SA ALIF Trial, 30Dx40Wx16H, 25°
• 00889929043806: SA ALIF Trial, 30Dx40Wx14H, 25°
• 00889929043790: SA ALIF Trial, 30Dx40Wx20H, 20°
• 00889929043783: SA ALIF Trial, 30Dx40Wx18H, 20°
• 00889929043776: SA ALIF Trial, 30Dx40Wx16H, 20°
• 00889929043769: SA ALIF Trial, 30Dx40Wx14H, 20°
• 00889929043752: SA ALIF Trial, 30Dx40Wx20H, 14°
• 00889929043745: SA ALIF Trial, 30Dx40Wx18H, 14°
• 00889929043738: SA ALIF Trial, 30Dx40Wx16H, 14°
• 00889929043721: SA ALIF Trial, 30Dx40Wx14H, 14°
• 00889929043714: SA ALIF Trial, 30Dx40Wx12H, 14°
• 00889929043707: SA ALIF Trial, 30Dx40Wx10H, 14°
• 00889929043691: SA ALIF Trial, 30Dx40Wx18H, 8°
• 00889929043684: SA ALIF Trial, 30Dx40Wx16H, 8°
• 00889929043677: SA ALIF Trial, 30Dx40Wx14H, 8°
• 00889929043660: SA ALIF Trial, 30Dx40Wx12H, 8°
• 00889929043653: SA ALIF Trial, 30Dx40Wx10H, 8°
• 00889929043646: SA ALIF Trial, 27Dx36Wx20H, 25°
• 00889929043639: SA ALIF Trial, 27Dx36Wx18H, 25°
• 00889929043622: SA ALIF Trial, 27Dx36Wx16H, 25°
• 00889929043615: SA ALIF Trial, 27Dx36Wx14H, 25°
• 00889929043608: SA ALIF Trial, 27Dx36Wx20H, 20°
• 00889929043592: SA ALIF Trial, 27Dx36Wx18H, 20°
• 00889929043585: SA ALIF Trial, 27Dx36Wx16H, 20°
• 00889929043578: SA ALIF Trial, 27Dx36Wx14H, 20°
• 00889929043561: SA ALIF Trial, 27Dx36Wx12H, 20°
• 00889929043554: SA ALIF Trial, 27Dx36Wx20H, 14°
• 00889929043547: SA ALIF Trial, 27Dx36Wx18H, 14°
• 00889929043530: SA ALIF Trial, 27Dx36Wx16H, 14°
• 00889929043523: SA ALIF Trial, 27Dx36Wx14H, 14°
• 00889929043516: SA ALIF Trial, 27Dx36Wx12H, 14°
• 00889929043509: SA ALIF Trial, 27Dx36Wx10H, 14°
• 00889929043493: SA ALIF Trial, 27Dx36Wx18H, 8°