KODIAK CERVICAL IMPLANT, 12x14mm, 8mmx6°

FDA UDI

Class II (US FDA UDI)

by Met 1 Technologies, Llc

Identity

Trade Name: KODIAK CERVICAL IMPLANT, 12x14mm, 8mmx6° FDA UDI
Generic Name: Metallic spinal interbody fusion cage FDA UDI
Device Name: THE MET ONE TECHNOLOGIES KODIAK C SPINAL INTERVERTEBRAL BODY FUSION DEVICE IS A CERVICAL INTERVERTEBRAL BODY FUSION DEVICE THAT IS IMPLANTED INTO THE VERTEBRAL BODY SPACE TO IMPROVE STABILITY OF THE SPINE WHILE SUPPORTING FUSION. A VARIETY OF IMPLANT SIZES ARE PROVIDED TO ACCOMMODATE INDIVIDUAL PATIENT ANATOMY. FDA UDI
Model / Reference: 31082406K FDA UDI
Description: THE MET ONE TECHNOLOGIES KODIAK C SPINAL INTERVERTEBRAL BODY FUSION DEVICE IS A CERVICAL INTERVERTEBRAL BODY FUSION DEVICE THAT IS IMPLANTED INTO THE VERTEBRAL BODY SPACE TO IMPROVE STABILITY OF THE SPINE WHILE SUPPORTING FUSION. A VARIETY OF IMPLANT SIZES ARE PROVIDED TO ACCOMMODATE INDIVIDUAL PATIENT ANATOMY. FDA UDI

Identifiers

Catalog Number: 31082406K FDA UDI
Primary DI / UDI-DI: 00819824025300 FDA UDI
510(k) Number: K222806 FDA UDI
FDA Product Code: ODP 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: 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

Yes

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

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Angle — 6 degree FDA UDI
Height — 8 Millimeter FDA UDI
Width — 14 Millimeter FDA UDI
Length — 12 Millimeter FDA UDI

Category: Metallic spinal interbody fusion cage

KODIAK CERVICAL IMPLANT, 12x14mm, 8mmx6° by Met 1 Technologies, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Metallic spinal interbody fusion cage.

Peridot-PT Anterior Cervical Intervertebral body fusion system — GBS Commonwealth Co., Ltd. · Class II
CoRoent — Nuvasive, Inc. · Class II
Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II
MectaLIF 3D — Medacta International · Class II
PILLAR TL — Orthofix US LLC · Class II
Solar™ Interbody Fusion System — Degen Medical · Class II
Peridot-TD Anterior Cervical Intervertebral body fusion system — GBS Commonwealth Co., Ltd. · Class II
ShurFit Lumbar Interbody — Precision Spine, Inc. · Class II

Cleared under the same submission

K222806 also covers:

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: Met 1 Technologies, Llc

Sources (1)

FDA UDI 6cddad8d-1507-4dc6-88f1-15948cf4b097 37 fields · synced May 30, 2026