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NEXXT MATRIXX® Stand Alone Cervical System

FDA UDI

Class II (US FDA UDI)

by Nexxt Spine Llc

Identity

Trade Name
NEXXT MATRIXX® Stand Alone Cervical System FDA UDI
Generic Name
General internal orthopaedic fixation system implantation kit FDA UDI
Device Name
SA Cervical, Screw Removal Tool, Sleeve FDA UDI
Model / Reference
I52-30-02 FDA UDI
Description
SA Cervical, Screw Removal Tool, Sleeve FDA UDI

Identifiers

Primary DI / UDI-DI
00889929026427 FDA UDI
510(k) Number
K190546 FDA UDI
FDA Product Code
OVE 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
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

NEXXT MATRIXX® Stand Alone Cervical System by Nexxt Spine Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K190546 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nexxt Spine Llc

Sources (1)

  • FDA UDI 5fa9fca9-8c48-492e-a087-526711ab5517 36 fields · synced May 31, 2026