HONOUR™ Spacer System

FDA UDI

Class II (US FDA UDI)

by Nexxt Spine Llc

Identity

Trade Name: HONOUR™ Spacer System FDA UDI
Generic Name: Vertebral body prosthesis, non-sterile FDA UDI
Device Name: TLIF, Parallel, 30mm L x 10mm W x 13mm H FDA UDI
Model / Reference: 15-1030-13P FDA UDI
Description: TLIF, Parallel, 30mm L x 10mm W x 13mm H FDA UDI

Identifiers

Primary DI / UDI-DI: 00889929001677 FDA UDI
510(k) Number: K120345 FDA UDI
FDA Product Code: MAX FDA UDI
ODP FDA UDI
MQP FDA UDI
GMDN Term: Vertebral body prosthesis, non-sterile FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3080 FDA UDI
888.3060 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

Dimensions & Sizes

Size: Height — 13 Millimeter FDA UDI
Width — 10 Millimeter FDA UDI
Length — 30 Millimeter FDA UDI

Category: Polymeric spinal interbody fusion cage Vertebral body prosthesis, non-sterile

HONOUR™ Spacer System by Nexxt Spine Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vertebral body prosthesis, non-sterile.

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Medyssey Poseidon OCT Spinal Fixation System — Medyssey Co., Ltd. · Class II
Vu aPod™ - L — SeaSpine Orthopedics Corporation · Class II
Apache — Genesys Orthopedics Systems LLC · Class II
SeaSpine Spacer System - Redondo™ — SeaSpine Orthopedics Corporation · Class II
Apache — Genesys Orthopedics Systems LLC · Class II

Cleared under the same submission

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 9cc85045-d429-4edd-96ca-56d9ce19b506 36 fields · synced May 30, 2026