KODIAK CORPECTOMY IMPLANT, 14x16mm, 35mmx0°

FDA UDI

Class II (US FDA UDI)

by Met 1 Technologies, Llc

Identity

Trade Name: KODIAK CORPECTOMY IMPLANT, 14x16mm, 35mmx0° FDA UDI
Generic Name: Vertebral body prosthesis FDA UDI
Device Name: THE MET ONE TECHNOLOGIES KODIAK C SPINAL VERTEBRAL BODY REPLACEMENT DEVICE IS A THORACOLUMBAR VERTEBRAL BODY REPLACEMENT DEVICE THAT IS IMPLANTED TO ACHIEVE ANTERIOR DECOMPRESSION OF THE SPINAL CORD AND NEURAL TISSUES AND TO RESTORE THE HEIGHT OF A COLLAPSED VERTEBRAL BODY. A VARIETY OF IMPLANT SIZES ARE PROVIDED TO ACCOMMODATE INDIVIDUAL PATIENT ANATOMY. FDA UDI
Model / Reference: 41354600K FDA UDI
Description: THE MET ONE TECHNOLOGIES KODIAK C SPINAL VERTEBRAL BODY REPLACEMENT DEVICE IS A THORACOLUMBAR VERTEBRAL BODY REPLACEMENT DEVICE THAT IS IMPLANTED TO ACHIEVE ANTERIOR DECOMPRESSION OF THE SPINAL CORD AND NEURAL TISSUES AND TO RESTORE THE HEIGHT OF A COLLAPSED VERTEBRAL BODY. A VARIETY OF IMPLANT SIZES ARE PROVIDED TO ACCOMMODATE INDIVIDUAL PATIENT ANATOMY. FDA UDI

Identifiers

Catalog Number: 41354600K FDA UDI
Primary DI / UDI-DI: 00819824026178 FDA UDI
510(k) Number: K222806 FDA UDI
FDA Product Code: MQP FDA UDI
GMDN Term: Vertebral body prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3060 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 — 0 degree FDA UDI
Height — 35 Millimeter FDA UDI
Width — 16 Millimeter FDA UDI
Length — 14 Millimeter FDA UDI

Category: Vertebral body prosthesis

KODIAK CORPECTOMY IMPLANT, 14x16mm, 35mmx0° by Met 1 Technologies, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vertebral body prosthesis.

CASCADIA™ Interbody System — K2M, INC. · Class II
CHESAPEAKE® Stabilization System — K2M, INC. · Class II
CASCADIA™ Interbody System — K2M, INC. · Class II
FORTIFY — GLOBUS MEDICAL, INC. · Class II
VERTE-STACK® Spinal System — MEDTRONIC SOFAMOR DANEK, INC. · Class II
CASCADIA™ Interbody System — K2M, INC. · Class II
CAPRI™ Corpectomy Cage System — K2M, INC. · Class II
Cascadia™ Interbody System — K2M, 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 ceea91ca-e851-44b8-9b20-71bd06f7cbf8 37 fields · synced Jun 1, 2026