Duo Ti Expandable Interbody Fusion System

FDA UDI

Class I (US FDA UDI)

by Spineology Inc.

Identity

Trade Name: Duo Ti Expandable Interbody Fusion System FDA UDI
Generic Name: Metallic spinal interbody fusion cage FDA UDI
Device Name: Straight Osteotome FDA UDI
Model / Reference: 86-11-31 FDA UDI
Description: Straight Osteotome FDA UDI

Identifiers

Catalog Number: 861-0052 FDA UDI
Primary DI / UDI-DI: M7408610052 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Metallic spinal interbody fusion cage FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Metallic spinal interbody fusion cage

The Duo Ti Expandable Interbody Fusion System is a cutting-edge medical device designed for orthopedic surgeons to treat degenerative disc disease (DDD). This innovative interbody fusion system utilizes a metallic spinal interbody cage in the form of a hollow, porous, threaded, and/or fenestrated cylindrical or disc-shaped device made of metal titanium (Ti), providing mechanical stability and sufficient space for therapeutic spinal bone fusion to occur. Bone graft is typically used to facilitate osseointegration and enhance fixation. Duo Ti Expandable Interbody Fusion System features a straight osteotome design, allowing for accurate implantation and post-operative recovery.

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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 I	Pending data

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Manufacturer

Manufacturer: Spineology Inc.

Sources (1)

FDA UDI 1d8e97b1-b5a3-48a5-8a21-f4d23d3f6574 35 fields · synced Jul 31, 2026