Spira-V Open Matrix Corpectomy Cage
Spira-V Open Matrix Corpectomy Cage replaces a collapsed, damaged or unstable vertebral body in the thoracolumbar spine from T1 to L5 after tumor or trauma. It is used with supplemental…
Spira-V Open Matrix Corpectomy Cage replaces a collapsed, damaged or unstable vertebral body in the thoracolumbar spine from T1 to L5 after tumor or trauma. It is used with supplemental fixation.
Spiral support structures create a hollow chamber for autogenous bone graft. Rough upper and lower surfaces are designed to limit implant movement while fusion develops.
Listed Item
7° (3.5°/3.5°), 19H Implant
Graft Requirement
The cage must be packed with the patient’s own bone graft material. The listed lordotic implant is one configuration within the corpectomy cage family, selected for the vertebral space being reconstructed. It functions as part of a stabilized spinal reconstruction.
Who Else Makes It
Concentrated in Shanghai (1), Jiangsu (1), Shandong (1). 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 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Camber Spine Technologies, United States |
|---|---|
| FDA product code | MQP |
| Device type | Spinal Vertebral Body Replacement Device |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K173800 |
| Record published | 2018-07-27 |
| Record revised | 2020-02-05 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SPV-12145-0727 | In distribution | |
| SPV-12145-0721 | In distribution | |
| SPV-12145-0723 | In distribution | |
| SPV-12145-3519 | In distribution | |
| SPV-12145-0717 | In distribution | |
| SPV-12145-0731 | In distribution | |
| SPV-12145-0719 | In distribution | |
| SPV-12145-0715 | In distribution | |
| SPV-12145-3531 | In distribution | |
| SPV-12145-3517 | In distribution | |
| SPV-12145-3525 | In distribution | |
| SPV-12145-0733 | In distribution | |
| SPV-12145-3515 | In distribution | |
| SPV-12145-0725 | In distribution | |
| SPV-12145-3523 | In distribution | |
| SPV-12145-3529 | In distribution | |
| SPV-12145-0729 | In distribution | |
| SPV-12145-3521 | In distribution | |
| SPV-12145-3533 | In distribution | |
| SPV-12145-3527 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CoRoent | Nuvasive, Inc. | 1,514 |
| Capri™ Corpectomy Cage System | VB Spine LLC | 1,509 |
| Aleutian® Interbody Systems | VB Spine LLC | 1,189 |
| Fortify | Globus Medical, Inc. | 866 |
| Matrixx System | Nexxt Spine LLC | 748 |
| Ascend | Alphatec Spine, Inc. | 555 |
| Zavation VBR Trial | Zavation | 548 |
| Verte-Stack® Spinal System | Medtronic Sofamor Danek, Inc. | 484 |
| Timberline® Lateral Interbody Fusion System | Biomet Spine | 470 |
| Timberline Lateral Fusion System | Biomet Spine | 459 |
| Novel | Alphatec Spine, Inc. | 447 |
| Hawkeye™ Vertebral Body Replacement (VBR) | Choice Spine, LP | 368 |
Showing 12 of 683. All products under Spinal Vertebral Body Replacement Device
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K173800 | 2018-02-02 |
| K143490 | 2015-01-26 |
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.