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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
Straight Lumbar Spacer Aggressive, 22mm L x 9mm W x 8mm H FDA UDI
Model / Reference
22-229-08 FDA UDI
Description
Straight Lumbar Spacer Aggressive, 22mm L x 9mm W x 8mm H FDA UDI

Identifiers

Primary DI / UDI-DI
00889929002445 FDA UDI
510(k) Number
K120345 FDA UDI
FDA Product Code
MAX FDA UDI
ODP FDA UDI
MQP FDA UDI
GMDN Term
Polymeric spinal interbody fusion cage FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3080 FDA UDI
888.3060 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Height — 8 Millimeter FDA UDI
Width — 9 Millimeter FDA UDI
Length — 22 Millimeter FDA UDI

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

Cleared under the same submission

K120345 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 fb0b07e8-ff7d-4714-b192-d290054aae2e 37 fields · synced Jun 1, 2026