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: Cervical PEEK, 10°, 18Wx16Dx14H FDA UDI
Model / Reference: 35-1618-140-10 FDA UDI
Description: Cervical PEEK, 10°, 18Wx16Dx14H FDA UDI

Identifiers

Primary DI / UDI-DI: 00889929009680 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

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Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

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Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

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Expiration Date

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Manufacturing Date

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Angle — 10 degree FDA UDI
Width — 18 Millimeter FDA UDI
Depth — 16 Millimeter FDA UDI
Height — 14 Millimeter FDA UDI

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

A comprehensive cervical PEEK, non-sterile implantable device designed to replace or repair spinal bony segments or vertebrae lost or injured as a consequence of trauma, deformity, tumour, or degenerative disease. It is typically intended to be used with supplemental spinal fixation and may be used with a bone graft. This device must be sterilized prior to use.

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 922cf142-15e6-47c7-93d1-811b65b36ab5 36 fields · synced Aug 4, 2026