T-FIX®3DSI Joint Fusion System

GUDID 00841193127989

T-FIX®3DSI Insertion Sleeve Gen 2

Cutting Edge Spine, LLC

Orthopaedic implant driver

• Primary Device ID: 00841193127989
• NIH Device Record Key: 1c95b3d7-bc6b-4c62-9fe3-b9b5ca1a72e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: T-FIX®3DSI Joint Fusion System
• Version Model Number: CES-550
• Company DUNS: 069472647
• Company Name: Cutting Edge Spine, LLC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 704-243-0892
• Email: b.roof@cuttingedgespine.com
• Phone: 704-243-0892
• Email: b.roof@cuttingedgespine.com
• Phone: 704-243-0892
• Email: b.roof@cuttingedgespine.com
• Phone: 704-243-0892
• Email: b.roof@cuttingedgespine.com
• Phone: 704-243-0892
• Email: b.roof@cuttingedgespine.com
• Phone: 704-243-0892
• Email: b.roof@cuttingedgespine.com
• Phone: 704-243-0892
• Email: b.roof@cuttingedgespine.com
• Phone: 704-243-0892
• Email: b.roof@cuttingedgespine.com
• Phone: 704-243-0892
• Email: b.roof@cuttingedgespine.com
• Phone: 704-243-0892
• Email: b.roof@cuttingedgespine.com
• Phone: 704-243-0892
• Email: b.roof@cuttingedgespine.com
• Phone: 704-243-0892
• Email: b.roof@cuttingedgespine.com
• Phone: 704-243-0892
• Email: b.roof@cuttingedgespine.com
• Phone: 704-243-0892
• Email: b.roof@cuttingedgespine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841193127989 [Primary]

FDA Product Code

• OUR: Sacroiliac Joint Fixation

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00841193127989]

Moist Heat or Steam Sterilization

[00841193127989]

Moist Heat or Steam Sterilization

[00841193127989]

Moist Heat or Steam Sterilization

[00841193127989]

Moist Heat or Steam Sterilization

[00841193127989]

Moist Heat or Steam Sterilization

[00841193127989]

Moist Heat or Steam Sterilization

[00841193127989]

Moist Heat or Steam Sterilization

[00841193127989]

Moist Heat or Steam Sterilization

[00841193127989]

Moist Heat or Steam Sterilization

[00841193127989]

Moist Heat or Steam Sterilization

[00841193127989]

Moist Heat or Steam Sterilization

[00841193127989]

Moist Heat or Steam Sterilization

[00841193127989]

Moist Heat or Steam Sterilization

[00841193127989]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-04
• Device Publish Date: 2025-07-25

Devices Manufactured by Cutting Edge Spine, LLC

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• 00841193127538 - EVOL®ha-Hyper C Cervical Interbody System: 2026-03-19 EVOL® HA Cervical Cage 14x12x06x7 deg
• 00841193127545 - EVOL®ha-Hyper C Cervical Interbody System: 2026-03-19 EVOL® HA Cervical Cage 14x12x07x7 deg
• 00841193127552 - EVOL®ha-Hyper C Cervical Interbody System: 2026-03-19 EVOL® HA Cervical Cage 14x12x08x7 deg
• 00841193127569 - EVOL®ha-Hyper C Cervical Interbody System: 2026-03-19 EVOL® HA Cervical Cage 14x12x09x7 deg
• 00841193127576 - EVOL®ha-Hyper C Cervical Interbody System: 2026-03-19 EVOL® HA Cervical Cage 14x12x10x7 deg
• 00841193127583 - EVOL®ha-Hyper C Cervical Interbody System: 2026-03-19 EVOL® HA Cervical Cage 14x12x11x7 deg