Translace™ Spinal Tethering System
Tether 9010007014 0.4MM Insert Assembly
1manufacturer
14catalogue numbers in this listing
Who Else Makes It
Registered in Shandong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
Record
| Listed by | Medtronic Sofamor Danek, Inc., United States |
|---|---|
| FDA product code | OWI |
| Device type | Bone Fixation Cerclage, Sublaminar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3010 |
| 510(k) | K163181 |
| Record published | 2024-11-04 |
| Record revised | 2022-09-16 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8239000 | In distribution | |
| 8239000 | In distribution | |
| 9010007014 | Thick | In distribution |
| 8239100 | In distribution | |
| 8205300 | In distribution | |
| 8205300 | In distribution | |
| 9010007012 | Thick | In distribution |
| 8239100 | In distribution | |
| 8219500 | In distribution | |
| 8219500 | In distribution | |
| 8239000 | In distribution | |
| 9010007013 | Thick | In distribution |
| 8205300 | In distribution | |
| 8219500 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Jazz System | Implanet | 118 |
| Hiline | Globus Medical, Inc. | 22 |
| Ligapass | Medicrea International | 20 |
| Nile™ Alternative Fixation System | VB Spine LLC | 13 |
| Nile™ Proximal Fixation System | VB Spine LLC | 13 |
| Universal Clamp ™ | Zimmer Spine, Inc. | 9 |
| VersaTie | Nuvasive, Inc. | 8 |
| Silc | Globus Medical, Inc. | 8 |
| Mariner Cap | Seaspine Orthopedics Corporation | 7 |
| Jazz Lock | Implanet | 6 |
| Invictus | Alphatec Spine, Inc. | 5 |
| Karma | Spinal Elements, Inc. | 3 |
Showing 12 of 20. All products under Bone Fixation Cerclage, Sublaminar
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.