HONOUR™ Spacer System

FDA UDI

Class II (US FDA UDI)

by Nexxt Spine Llc

Identity

Trade Name: HONOUR™ Spacer System FDA UDI
Generic Name: Polymeric spinal interbody fusion cage FDA UDI
Device Name: TLIF, Aggressive, Lordotic, 30mm x 7mm x 6° FDA UDI
Model / Reference: 16-1030-07L FDA UDI
Description: TLIF, Aggressive, Lordotic, 30mm x 7mm x 6° FDA UDI

Identifiers

Primary DI / UDI-DI: 00889929001738 FDA UDI
510(k) Number: K120345 FDA UDI
FDA Product Code: MQP FDA UDI
ODP FDA UDI
MAX FDA UDI
GMDN Term: Polymeric spinal interbody fusion cage FDA UDI

Classification

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

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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: Length — 30 Millimeter FDA UDI
Height — 7 Millimeter FDA UDI
Angle — 6 degree FDA UDI

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

The HONOUR Spacer System is a non-sterile, implantable device designed to replace or repair the spinal bony segments lost or injured due to trauma, deformity, tumor, or degenerative disease. This polymeric spinal interbody fusion cage provides mechanical stability and sufficient space for therapeutic spinal bone fusion, typically in conjunction with supplemental spinal fixation and bone grafts.

Similar devices

Also classified as Vertebral body prosthesis, non-sterile.

L-Box® — Innovasis, Inc. · Class II
Zavation — ZAVATION · Class II
Medyssey Poseidon OCT Spinal Fixation System — Medyssey Co., Ltd. · Class II
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 9ace139c-545f-4dea-bb1d-a8661026f34b 36 fields · synced Jul 9, 2026