← Back to catalogue

KODIAK PLIF IMPLANT 13x22mm, 0°

FDA UDI

Class II (US FDA UDI)

by Met 1 Technologies, Llc

Identity

Trade Name
KODIAK PLIF IMPLANT 13x22mm, 0° FDA UDI
Generic Name
Metallic spinal interbody fusion cage FDA UDI
Device Name
The Met One Technologies Kodiak Lumbar Spacer System is a lumbar intervertebral body fusion device that is implanted into the vertebral body space to improve stability of the spine while supporting fusion. The Kodiak Lumbar Spacer System may be implanted bilaterally using a posterior (PLIF) approach, or as a single device employing a transformational (TLIF) approach. The implants have a central endplate window to permit packing of autograft and/or allograft bone, teeth on the superior and inferior surfaces, and lateral windows for radiographic visualization. The implants are additively manufactured from Ti-6Al-4V ELI and are available in a variety of heights, footprints, and lordotic configurations to suit individual patient anatomy. FDA UDI
Model / Reference
10221300K FDA UDI
Description
The Met One Technologies Kodiak Lumbar Spacer System is a lumbar intervertebral body fusion device that is implanted into the vertebral body space to improve stability of the spine while supporting fusion. The Kodiak Lumbar Spacer System may be implanted bilaterally using a posterior (PLIF) approach, or as a single device employing a transformational (TLIF) approach. The implants have a central endplate window to permit packing of autograft and/or allograft bone, teeth on the superior and inferior surfaces, and lateral windows for radiographic visualization. The implants are additively manufactured from Ti-6Al-4V ELI and are available in a variety of heights, footprints, and lordotic configurations to suit individual patient anatomy. FDA UDI

Identifiers

Catalog Number
10221300K FDA UDI
Primary DI / UDI-DI
00819824027915 FDA UDI
510(k) Number
K230851 FDA UDI
FDA Product Code
MAX 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Angle — 0 degree FDA UDI
Height — 13 Millimeter FDA UDI
Width — 9 Millimeter FDA UDI
Length — 22 Millimeter FDA UDI

Category: Metallic spinal interbody fusion cage

KODIAK PLIF IMPLANT 13x22mm, 0° 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.

Cleared under the same submission

K230851 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Met 1 Technologies, Llc

Sources (1)

  • FDA UDI 72e831c8-b6e7-41f1-ab94-c72c7e26079d 37 fields · synced Jun 1, 2026