Matrixx System

FDA UDI

Class II (US FDA UDI)

by Nexxt Spine Llc

Identity

Trade Name: Matrixx System FDA UDI
Generic Name: General internal orthopaedic fixation system implantation kit FDA UDI
Device Name: Monolythic Lateral Trial, 22Wx8H, 0° FDA UDI
Model / Reference: I62-STR-22-08-0 FDA UDI
Description: Monolythic Lateral Trial, 22Wx8H, 0° FDA UDI

Identifiers

Primary DI / UDI-DI: 00889929048252 FDA UDI
510(k) Number: K200969 FDA UDI
FDA Product Code: MAX FDA UDI
GMDN Term: General internal orthopaedic fixation system implantation kit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3080 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: General internal orthopaedic fixation system implantation kit

The Matrixx System is a cutting-edge, monolythic lateral trial orthopedic fixation system designed for minimally invasive spine fusion procedures. Featuring a unique design with integrated bone grafts and a durable metal framework, this device provides superior stability and performance in achieving successful spinal fusion outcomes.

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Cleared under the same submission

K200969 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Nexxt Spine Llc

Sources (1)

FDA UDI c65bbdc5-19aa-4718-9ec5-2b9d5c2e17d9 35 fields · synced Jul 22, 2026

Matrixx System

Identity

Identifiers

Classification

Clinical & Handling

Similar devices

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

Manufacturer

Sources (1)