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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
Metallic spinal interbody fusion cage FDA UDI
Device Name
SA Cervical Interbody, 14Dx16Wx12H FDA UDI
Model / Reference
52-1416-12-SP FDA UDI
Description
SA Cervical Interbody, 14Dx16Wx12H FDA UDI

Identifiers

Primary DI / UDI-DI
00889929030493 FDA UDI
510(k) Number
K190546 FDA UDI
FDA Product Code
OVE FDA UDI
GMDN Term
Metallic spinal interbody fusion cage 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Width — 16 Millimeter FDA UDI
Depth — 14 Millimeter FDA UDI
Height — 12 Millimeter FDA UDI
Angle — 6 degree 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 c23963ce-4e8d-41b4-b1cc-308a9a30bd4d 37 fields · synced Jun 6, 2026