T-FIX™3Dsi Joint Fusion System
GUDID 00841193125763
T-FIX™ 3DSI Screw, 13 x 25, Fully Threaded, HA-nano
Cutting Edge Spine, LLC
Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, sterile| Primary Device ID | 00841193125763 |
| NIH Device Record Key | 2d12ffbf-e630-4c2d-92e7-20df194bb891 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | T-FIX™3Dsi Joint Fusion System |
| Version Model Number | HA5007-25FT |
| Company DUNS | 069472647 |
| Company Name | Cutting Edge Spine, LLC |
| Device Count | 1 |
| DM Exempt | false |
| 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 | true |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841193125763 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K214123
FDA Product Code
| OUR | Sacroiliac Joint Fixation |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-08-08 |
| Device Publish Date | 2022-07-29 |
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 |
Trademark Results [T-FIX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 T-FIX 88688482 not registered Live/Pending |
Cutting Edge Spine, LLC 2019-11-12 |
 T-FIX 85196761 not registered Dead/Abandoned |
VITAL PHARMACEUTICALS, INC. 2010-12-13 |
 T-FIX 74416076 1877142 Live/Registered |
SMITH & NEPHEW, INC. 1993-07-23 |
 T-FIX 72261846 0851759 Dead/Expired |
ILLINOIS-WATER TREATMENT COMPANY 1967-01-03 |
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