T-FIX™3Dsi Joint Fusion System

GUDID 00841193126142

T-FIX™ 3DSI Screw, 13 x 70, Fully Threaded, Non-Coated

Cutting Edge Spine, LLC

Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated

• Primary Device ID: 00841193126142
• NIH Device Record Key: 03b95139-ec4e-4f1f-a836-f81944038e1c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: T-FIX™3Dsi Joint Fusion System
• Version Model Number: NC5007-70FT
• 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: true
• Lot Batch: true
• Serial Number: false
• 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: 7042430892
• Email: b.roof@cuttingedgespine.com
• Phone: 7042430892
• Email: b.roof@cuttingedgespine.com
• Phone: 7042430892
• Email: b.roof@cuttingedgespine.com
• Phone: 7042430892
• Email: b.roof@cuttingedgespine.com
• Phone: 7042430892
• Email: b.roof@cuttingedgespine.com
• Phone: 7042430892
• Email: b.roof@cuttingedgespine.com
• Phone: 7042430892
• Email: b.roof@cuttingedgespine.com
• Phone: 7042430892
• Email: b.roof@cuttingedgespine.com
• Phone: 7042430892
• Email: b.roof@cuttingedgespine.com
• Phone: 7042430892
• Email: b.roof@cuttingedgespine.com
• Phone: 7042430892
• Email: b.roof@cuttingedgespine.com
• Phone: 7042430892
• Email: b.roof@cuttingedgespine.com
• Phone: 7042430892
• Email: b.roof@cuttingedgespine.com
• Phone: 7042430892
• Email: b.roof@cuttingedgespine.com
• Phone: 7042430892
• Email: b.roof@cuttingedgespine.com
• Phone: 7042430892
• Email: b.roof@cuttingedgespine.com
• Phone: 7042430892
• Email: b.roof@cuttingedgespine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841193126142 [Primary]

FDA Product Code

• OUR: Sacroiliac Joint Fixation

Sterilization

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

[00841193126142]

Moist Heat or Steam Sterilization

[00841193126142]

Moist Heat or Steam Sterilization

[00841193126142]

Moist Heat or Steam Sterilization

[00841193126142]

Moist Heat or Steam Sterilization

[00841193126142]

Moist Heat or Steam Sterilization

[00841193126142]

Moist Heat or Steam Sterilization

[00841193126142]

Moist Heat or Steam Sterilization

[00841193126142]

Moist Heat or Steam Sterilization

[00841193126142]

Moist Heat or Steam Sterilization

[00841193126142]

Moist Heat or Steam Sterilization

[00841193126142]

Moist Heat or Steam Sterilization

[00841193126142]

Moist Heat or Steam Sterilization

[00841193126142]

Moist Heat or Steam Sterilization

[00841193126142]

Moist Heat or Steam Sterilization

[00841193126142]

Moist Heat or Steam Sterilization

[00841193126142]

Moist Heat or Steam Sterilization

[00841193126142]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-01
• Device Publish Date: 2023-04-21

On-Brand Devices [T-FIX™3Dsi Joint Fusion System]

• 00841193125855: T-FIX™ 3DSI Screw, 13.0 x 70, Fully Threaded, HA-nano
• 00841193125848: T-FIX™ 3DSI Screw, 13.0 x 65, Fully Threaded, HA-nano
• 00841193125831: T-FIX™ 3DSI Screw, 13.0 x 60, Fully Threaded, HA-nano
• 00841193125824: T-FIX™ 3DSI Screw, 13.0 x 55, Fully Threaded, HA-nano
• 00841193125817: T-FIX™ 3DSI Screw, 13.0 x 50, Fully Threaded, HA-nano
• 00841193125800: T-FIX™ 3DSI Screw, 13.0 x 45, Fully Threaded, HA-nano
• 00841193125794: T-FIX™ 3DSI Screw, 13.0 x 40, Fully Threaded, HA-nano
• 00841193125787: T-FIX™ 3DSI Screw, 13.0 x 35, Fully Threaded, HA-nano
• 00841193125770: T-FIX™ 3DSI Screw, 13.0 x 30, Fully Threaded, HA-nano
• 00841193125763: T-FIX™ 3DSI Screw, 13 x 25, Fully Threaded, HA-nano
• 00841193125756: T-FIX™ 3DSI Screw, 11.5 x 70, Fully Threaded, HA-nano
• 00841193125749: T-FIX™ 3DSI Screw, 11.5 x 65, Fully Threaded, HA-nano
• 00841193125732: T-FIX™ 3DSI Screw, 11.5 x 60, Fully Threaded, HA-nano
• 00841193125725: T-FIX™ 3DSI Screw, 11.5 x 55, Fully Threaded, HA-nano
• 00841193125718: T-FIX™ 3DSI Screw, 11.5 x 50, Fully Threaded, HA-nano
• 00841193125701: T-FIX™ 3DSI Screw, 11.5 x 45, Fully Threaded, HA-nano
• 00841193125695: T-FIX™ 3DSI Screw, 11.5 x 40, Fully Threaded, HA-nano
• 00841193125688: T-FIX™ 3DSI Screw, 11.5 x 35, Fully Threaded, HA-nano
• 00841193125671: T-FIX™ 3DSI Screw, 11.5 x 30, Fully Threaded, HA-nano
• 00841193125664: T-FIX™ 3DSI Screw, 11.5 x 25, Fully Threaded, HA-nano
• 00841193125473: T-FIX™ 3DSI Screw, 13 x 70, Partially Threaded, HA-nano
• 00841193125466: T-FIX™ 3DSI Screw, 13 x 65, Partially Threaded, HA-nano
• 00841193125459: T-FIX™ 3DSI Screw, 13 x 60, Partially Threaded, HA-nano
• 00841193125442: T-FIX™ 3DSI Screw, 13 x 55, Partially Threaded, HA-nano
• 00841193125435: T-FIX™ 3DSI Screw, 13 x 50, Partially Threaded, HA-nano
• 00841193125428: T-FIX™ 3DSI Screw, 13 x 45, Partially Threaded, HA-nano
• 00841193125411: T-FIX™ 3DSI Screw, 13 x 40, Partially Threaded, HA-nano
• 00841193125404: T-FIX™ 3DSI Screw, 13 x 35, Partially Threaded, HA-nano
• 00841193125398: T-FIX™ 3DSI Screw, 13 x 30, Partially Threaded, HA-nano
• 00841193125381: T-FIX™ 3DSI Screw, 11.5 x 70, Partially Threaded, HA-nano
• 00841193125374: T-FIX™ 3DSI Screw, 11.5 x 65, Partially Threaded, HA-nano
• 00841193125367: T-FIX™ 3DSI Screw, 11.5 x 60, Partially Threaded, HA-nano
• 00841193125350: T-FIX™ 3DSI Screw, 11.5 x 55, Partially Threaded, HA-nano
• 00841193125343: T-FIX™ 3DSI Screw, 11.5 x 50, Partially Threaded, HA-nano
• 00841193125336: T-FIX™ 3DSI Screw, 11.5 x 45, Partially Threaded, HA-nano
• 00841193125329: T-FIX™ 3DSI Screw, 11.5 x 40, Partially Threaded, HA-nano
• 00841193125312: T-FIX™ 3DSI Screw, 11.5 x 35, Partially Threaded, HA-nano
• 00841193125305: T-FIX™ 3DSI Screw, 11.5 x 30, Partially Threaded, HA-nano
• 00841193126142: T-FIX™ 3DSI Screw, 13 x 70, Fully Threaded, Non-Coated
• 00841193126135: T-FIX™ 3DSI Screw, 13 x 65, Fully Threaded, Non-Coated
• 00841193126128: T-FIX™ 3DSI Screw, 13 x 60, Fully Threaded, Non-Coated
• 00841193126111: T-FIX™ 3DSI Screw, 13 x 55, Fully Threaded, Non-Coated
• 00841193126104: T-FIX™ 3DSI Screw, 13 x 50, Fully Threaded, Non-Coated
• 00841193126098: T-FIX™ 3DSI Screw, 13 x 45, Fully Threaded, Non-Coated
• 00841193126081: T-FIX™ 3DSI Screw, 13 x 40, Fully Threaded, Non-Coated
• 00841193126074: T-FIX™ 3DSI Screw, 13 x 35, Fully Threaded, Non-Coated
• 00841193126067: T-FIX™ 3DSI Screw, 13 x 30, Fully Threaded, Non-Coated
• 00841193126050: T-FIX™ 3DSI Screw, 13 x 25, Fully Threaded, Non-Coated
• 00841193126043: T-FIX™ 3DSI Screw, 11.5 x 70, Fully Threaded, Non-Coated
• 00841193126036: T-FIX™ 3DSI Screw, 11.5 x 65, Fully Threaded, Non-Coated