Matrixx System

GUDID 00889929038314

Lateral, 22Wx55Lx12H 14°

NEXXT SPINE, LLC

Metallic spinal interbody fusion cage

• Primary Device ID: 00889929038314
• NIH Device Record Key: 55f27547-67c2-4267-a0e0-a2884f576c7c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Matrixx System
• Version Model Number: 62-2255-12-14-SP
• 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: true
• 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

Device Dimensions

• Width: 55 Millimeter
• Height: 12 Millimeter
• Depth: 22 Millimeter
• Angle: 14 degree
• Width: 55 Millimeter
• Height: 12 Millimeter
• Depth: 22 Millimeter
• Angle: 14 degree
• Width: 55 Millimeter
• Height: 12 Millimeter
• Depth: 22 Millimeter
• Angle: 14 degree
• Width: 55 Millimeter
• Height: 12 Millimeter
• Depth: 22 Millimeter
• Angle: 14 degree
• Width: 55 Millimeter
• Height: 12 Millimeter
• Depth: 22 Millimeter
• Angle: 14 degree
• Width: 55 Millimeter
• Height: 12 Millimeter
• Depth: 22 Millimeter
• Angle: 14 degree
• Width: 55 Millimeter
• Height: 12 Millimeter
• Depth: 22 Millimeter
• Angle: 14 degree
• Width: 55 Millimeter
• Height: 12 Millimeter
• Depth: 22 Millimeter
• Angle: 14 degree
• Width: 55 Millimeter
• Height: 12 Millimeter
• Depth: 22 Millimeter
• Angle: 14 degree
• Width: 55 Millimeter
• Height: 12 Millimeter
• Depth: 22 Millimeter
• Angle: 14 degree
• Width: 55 Millimeter
• Height: 12 Millimeter
• Depth: 22 Millimeter
• Angle: 14 degree
• Width: 55 Millimeter
• Height: 12 Millimeter
• Depth: 22 Millimeter
• Angle: 14 degree
• Width: 55 Millimeter
• Height: 12 Millimeter
• Depth: 22 Millimeter
• Angle: 14 degree
• Width: 55 Millimeter
• Height: 12 Millimeter
• Depth: 22 Millimeter
• Angle: 14 degree
• Width: 55 Millimeter
• Height: 12 Millimeter
• Depth: 22 Millimeter
• Angle: 14 degree
• Width: 55 Millimeter
• Height: 12 Millimeter
• Depth: 22 Millimeter
• Angle: 14 degree

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889929038314 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200969

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-02-25
• Device Publish Date: 2020-11-09

On-Brand Devices [Matrixx System]

• 00889929032374: TLIF Oblique 30D x 10W x 16H
• 00889929032367: TLIF Oblique 30D x 10W x 15H
• 00889929032350: TLIF Oblique 22D x 9W x 16H
• 00889929032343: TLIF Oblique 22D x 9W x 15H
• 00889929032428: Matrixx, Paddle Distractor, 17mm
• 00889929032411: Matrixx, Paddle Distractor, 16mm
• 00889929032404: Matrixx, Paddle Distractor, 15mm
• 00889929032398: Matrixx, Paddle Distractor, 14mm
• 00889929032381: Matrixx, Paddle Distractor, 6mm
• 00889929032763: TLIF Offset Inserter, Outer Shaft Assembly
• 00889929032756: TLIF Oblique Offset Inserter, Inner Shaft
• 00889929032749: TLIF Oblique Offset Inserter, Outer Shaft Assembly
• 00889929032770: Universal Remover
• 00889929032732: Lordotic TLIFO Solid, 30Dx10Wx8H, 6°
• 00889929032725: Lordotic TLIFO Solid, 26Dx9Wx8H, 6°
• 00889929032718: Lordotic TLIFO Solid, 22Dx9Wx8H, 6°
• 00889929032701: Lordotic TLIFO, 30Dx10Wx16H, 6°
• 00889929032695: Lordotic TLIFO, 30Dx10Wx15H, 6°
• 00889929032688: Lordotic TLIFO, 30Dx10Wx14H, 6°
• 00889929032671: Lordotic TLIFO, 30Dx10Wx13H, 6°
• 00889929032664: Lordotic TLIFO, 30Dx10Wx12H, 6°
• 00889929032657: Lordotic TLIFO, 30Dx10Wx11H, 6°
• 00889929032640: Lordotic TLIFO, 30Dx10Wx10H, 6°
• 00889929032633: Lordotic TLIFO, 30Dx10Wx9H, 6°
• 00889929032626: Lordotic TLIFO, 30Dx10Wx8H, 6°
• 00889929032619: Lordotic TLIFO, 26Dx9Wx16H, 6°
• 00889929032602: Lordotic TLIFO, 26Dx9Wx15H, 6°
• 00889929032596: Lordotic TLIFO, 26Dx9Wx14H, 6°
• 00889929032589: Lordotic TLIFO, 26Dx9Wx13H, 6°
• 00889929032572: Lordotic TLIFO, 26Dx9Wx12H, 6°
• 00889929032565: Lordotic TLIFO, 26Dx9Wx11H, 6°
• 00889929032558: Lordotic TLIFO, 26Dx9Wx10H, 6°
• 00889929032541: Lordotic TLIFO, 26Dx9Wx9H, 6°
• 00889929032534: Lordotic TLIFO, 26Dx9Wx8H, 6°
• 00889929032527: Lordotic TLIFO, 22Dx9Wx16H, 6°
• 00889929032510: Lordotic TLIFO, 22Dx9Wx15H, 6°
• 00889929032503: Lordotic TLIFO, 22Dx9Wx14H, 6°
• 00889929032497: Lordotic TLIFO, 22Dx9Wx13H, 6°
• 00889929032480: Lordotic TLIFO, 22Dx9Wx12H, 6°
• 00889929032473: Lordotic TLIFO, 22Dx9Wx11H, 6°
• 00889929032466: Lordotic TLIFO, 22Dx9Wx10H, 6°
• 00889929032459: Lordotic TLIFO, 22Dx9Wx9H, 6°
• 00889929032442: Lordotic TLIFO, 22Dx9Wx8H, 6°
• 00889929032800: TLIF Axial Inserter, Outer Shaft Assembly
• 00889929032794: TLIF Oblique Axial Inserter, Inner Shaft Assembly
• 00889929032787: TLIF Oblique Axial Inserter, Outer Shaft Assembly
• 00889929033050: Curve Implant Tamp
• 00889929033043: TLIF Oblique Lordotic Trial, 30x10x13mm
• 00889929033036: TLIF Oblique Lordotic Trial, 30x10x12mm
• 00889929033029: TLIF Oblique Lordotic Trial, 30x10x11mm