T-FIX™3Dsi Joint Fusion System

FDA UDI

Class II (US FDA UDI)

by Cutting Edge Spine

Identity

Trade Name: T-FIX™3Dsi Joint Fusion System FDA UDI
Generic Name: Endoscopic-access dilator, reusable FDA UDI
Device Name: T-FIX™ Soft Tissue Paddle Dilator FDA UDI
Model / Reference: CES-549 FDA UDI
Description: T-FIX™ Soft Tissue Paddle Dilator FDA UDI

Identifiers

Primary DI / UDI-DI: 00841193126548 FDA UDI
FDA Product Code: OUR FDA UDI
GMDN Term: Endoscopic-access dilator, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 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

Category: Endoscopic-access dilator, reusable

T-FIX™3Dsi Joint Fusion System by Cutting Edge Spine — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscopic-access dilator, reusable.

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Arthrex® — Arthrex, Inc. · Class I
AVATAR Minimally Invasive Spinal System — Life Spine, Inc. · Class II
iLESSYS® — JOIMAX, INC. · Class I
Arthrex® — Arthrex, Inc. · Class I
TESSYS® — JOIMAX, INC. · Class I

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: Cutting Edge Spine

Sources (1)

FDA UDI d276a416-ce8d-46a3-a0c2-27a840ad5b50 34 fields · synced May 30, 2026