AxTiHA®

FDA UDI

Class II (US FDA UDI)

by Innovasis, Inc.

Identity

Trade Name: AxTiHA® FDA UDI
Generic Name: Metallic spinal interbody fusion cage FDA UDI
Device Name: Ti 6Al 4V (ELI); Hydroxyapatite FDA UDI
Model / Reference: AXTi204020 FDA UDI
Description: Ti 6Al 4V (ELI); Hydroxyapatite FDA UDI

Identifiers

Catalog Number: AXTi204020 FDA UDI
Primary DI / UDI-DI: M711AXTI2040200 FDA UDI
FDA Product Code: OVD 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

Yes

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

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Height — 20 Millimeter FDA UDI
Width — 40 Millimeter FDA UDI
Angle — 20 degree FDA UDI

Category: Metallic spinal interbody fusion cage

AxTiHA® by Innovasis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Metallic spinal interbody fusion cage.

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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

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: Innovasis, Inc.

Sources (1)

FDA UDI 030ebe46-48d8-4380-a515-9995241aed86 36 fields · synced Jun 8, 2026