IVA Cage Ti

FDA UDI

Class II (US FDA UDI)

by Dio Medical Co., Ltd.

Identity

Trade Name: IVA Cage Ti FDA UDI
Generic Name: Metallic spinal fusion cage, non-sterile FDA UDI
Device Name: Posterior Lumbar Interbody Fusion Titanium CageL30 x W10 x H8 x A0 FDA UDI
Model / Reference: A FDA UDI
Description: Posterior Lumbar Interbody Fusion Titanium CageL30 x W10 x H8 x A0 FDA UDI

Identifiers

Catalog Number: TPI.30100008 FDA UDI
Primary DI / UDI-DI: 08800039815642 FDA UDI
510(k) Number: K173080 FDA UDI
FDA Product Code: MAX FDA UDI
ODP FDA UDI
GMDN Term: Metallic spinal fusion cage, non-sterile 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

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

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Height — 8 Millimeter FDA UDI

Category: Metallic spinal fusion cage, non-sterile

IVA Cage Ti by Dio Medical Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Metallic spinal fusion cage, non-sterile.

Silverstone Titanium Interbody Fusion System — Altus Spine · Class II
Silverstone Titanium Interbody Fusion System — Altus Spine · Class II
TraXis® — ZIMMER SPINE, INC. · Class II
PLIF Cage — Eisertech, LLC · Class II
Copperhead — EMINENT SPINE LLC · Class II
SPIRA™-C Open Matrix Cervical Interbody — CAMBER SPINE TECHNOLOGIES · Class II
3DP Lumbar Interbody System — Genesys Orthopedics Systems LLC · Class II
SPIRA™-C Open Matrix Cervical Interbody — CAMBER SPINE TECHNOLOGIES · Class II

Cleared under the same submission

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: Dio Medical Co., Ltd.

Sources (1)

FDA UDI e54251d6-5477-4bd1-8649-bc2fbe479c8f 37 fields · synced May 30, 2026