Kodiak Pl Tl Graft Block

FDA UDI

Class II (US FDA UDI)

by Met 1 Technologies, Llc

Identity

Trade Name: KODIAK PL TL GRAFT BLOCK FDA UDI
Generic Name: Bone graft packing block 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: 04-07G 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: 04-07G FDA UDI
Primary DI / UDI-DI: 00819824028691 FDA UDI
510(k) Number: K230851 FDA UDI
FDA Product Code: MAX FDA UDI
GMDN Term: Bone graft packing block 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

FDA UDI

Implantable

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

Category: Bone graft packing block

Kodiak Pl Tl Graft Block by Met 1 Technologies, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 4fc3db66-35dc-4a10-9dfc-4efc9fce9111 36 fields · synced May 30, 2026

Kodiak Pl Tl Graft Block

Identity

Identifiers

Classification

Clinical & Handling

Similar devices

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

Manufacturer

Sources (1)