Trabis®
domed cage
1manufacturer
34catalogue numbers in this listing
1510(k) clearance
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 | Coligne AG, Switzerland |
|---|---|
| FDA product code | PLR |
| Device type | Spinal Vertebral Body Replacement Device – Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Manufacturer |
| 510(k) | K173893 |
| Record published | 2018-09-11 |
| Record revised | 2020-02-24 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| P15-010-17 | In distribution | |
| P15-010-13 | In distribution | |
| P15-010-03 | In distribution | |
| 015.030.206 | In distribution | |
| P15-010-10 | In distribution | |
| 015.030.251 | In distribution | |
| P15-010-05 | In distribution | |
| P15-010-15 | In distribution | |
| P15-010-01 | In distribution | |
| 015.030.191 | In distribution | |
| P15-010-14 | In distribution | |
| P15-010-11 | In distribution | |
| P15-010-02 | In distribution | |
| 015.030.176 | In distribution | |
| 015.030.351 | In distribution | |
| P15-010-09 | In distribution | |
| 015.030.476 | In distribution | |
| P15-010-04 | In distribution | |
| P15-010-06 | In distribution | |
| 015.030.501 | In distribution | |
| 015.030.401 | In distribution | |
| P15-010-08 | In distribution | |
| 015.030.236 | In distribution | |
| 015.030.426 | In distribution | |
| P15-010-16 | In distribution | |
| 015.030.276 | In distribution | |
| 015.030.451 | In distribution | |
| 015.030.376 | In distribution | |
| 015.030.326 | In distribution | |
| 015.030.221 | In distribution | |
| P15-010-12 | In distribution | |
| 015.030.526 | In distribution | |
| P15-010-07 | In distribution | |
| 015.030.301 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Alta | Astura Medical | 290 |
| Ascend | Alphatec Spine, Inc. | 267 |
| Matrixx System | Nexxt Spine LLC | 88 |
| Colosseum | Globus Medical, Inc. | 87 |
| Palo Alto Corpectomy Cage System | VB Spine LLC | 56 |
| C-VBR | VB Spine LLC | 53 |
| X-Core | Nuvasive, Inc. | 31 |
| CarboClear Cervical VBR System | CarboFix Orthopedics, Ltd. | 31 |
| Capri™ Corpectomy Cage System | VB Spine LLC | 25 |
| Zavation | Zavation | 25 |
| Verteloc Spinal System | Signature Orthopaedics PTY Limited | 17 |
| Fortify | Globus Medical, Inc. | 14 |
Showing 12 of 31. All products under Spinal Vertebral Body Replacement Device – Cervical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K173893 | 2018-09-06 |
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.