Hiline
Adjustable Ratcheting Tensioner
1manufacturer
22catalogue numbers in this listing
3510(k) clearances naming this product code
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 | Globus Medical, Inc., United States |
|---|---|
| FDA product code | OWI |
| Device type | Bone Fixation Cerclage, Sublaminar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3010 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K230565 |
| Record published | 2024-07-22 |
| Record revised | 2025-07-02 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1230.1055 | In distribution | |
| 1230.0014S | In distribution | |
| 6230.1000 | In distribution | |
| 6230.2001 | In distribution | |
| 6230.0080 | In distribution | |
| 1230.1135 | In distribution | |
| 1230.1145 | In distribution | |
| 6230.0070 | In distribution | |
| 1230.1035 | In distribution | |
| 1230.1045 | In distribution | |
| 6230.1010 | In distribution | |
| 1230.1165 | In distribution | |
| 1230.1000 | In distribution | |
| 1230.0006S | In distribution | |
| 1230.1065 | In distribution | |
| 6230.0090 | In distribution | |
| 6230.2002 | In distribution | |
| 6230.2025 | In distribution | |
| 6230.2020 | In distribution | |
| 1230.0004S | In distribution | |
| 6230.2030 | In distribution | |
| 1230.1155 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Jazz System | Implanet | 118 |
| Ligapass | Medicrea International | 20 |
| Translace™ Spinal Tethering System | Medtronic Sofamor Danek, Inc. | 14 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K230565 | 2023-04-20 |
| K172417 | 2017-10-26 |
| K133482 | 2014-05-21 |
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.