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

• 00841193127989 - T-FIX®3DSI Joint Fusion System: 2025-08-04T-FIX®3DSI Insertion Sleeve Gen 2
• 00841193127989 - T-FIX®3DSI Joint Fusion System: 2025-08-04 T-FIX®3DSI Insertion Sleeve Gen 2
• 00841193124995 - EVOL®SI Joint Fusion System: 2024-05-06 EVOL®SI Stackable Steinmann Pin, 3.2 Blunt End
• 00841193126562 - T-FIX™3Dsi Joint Fusion System: 2024-04-15 T-FIX™ Bridging Joint Finder
• 00841193125190 - T-FIX™3Dsi Joint Fusion System: 2024-03-20 T-FIX™ Wire Impaction Cap
• 00841193126234 - T-FIX™3Dsi Joint Fusion System: 2024-03-20 T-FIX™ One Step Dilator
• 00841193126548 - T-FIX™3Dsi Joint Fusion System: 2024-03-20 T-FIX™ Soft Tissue Paddle Dilator
• 00841193126487 - EVOS Lumbar Interbody System: 2024-02-19 11x10x30L Biconvex 15 Deg Curved Cage
• 00841193126494 - EVOS Lumbar Interbody System: 2024-02-19 12x10x30L Biconvex 15 Deg Curved Cage