Supstance Small
The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR) system intended to replace a vertebral body. It is designed for use in the cervical and in the thoracolumbar…
The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR) system intended to replace a vertebral body. It is designed for use in the cervical and in the thoracolumbar spine (C3 – L5) to replace a collapsed, damaged or unstable vertebral body during tumor or trauma management and to replace a partially removed vertebral body in the management of degenerative disorders.
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 | H.P.I. |
|---|---|
| FDA product code | MQP |
| Device type | Spinal Vertebral Body Replacement Device |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Record published | 2015-11-12 |
| Record revised | 2020-02-24 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Label carries | lot or batch number |
| Sizes | Width 12 to 16 mm; length 18 to 50 mm; angle 0 to 8 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 100114838 | Width 14 mm | In distribution |
| 100116036 | Angle 0 ° | In distribution |
| 100116018 | Width 16 mm | In distribution |
| 100116044 | Angle 0 ° | In distribution |
| 100114524 | Angle 5 ° | In distribution |
| 100112518 | Width 12 mm | In distribution |
| 100114834 | Width 14 mm | In distribution |
| 100116020 | Angle 0 ° | In distribution |
| 100116042 | Width 16 mm | In distribution |
| 100116028 | Angle 0 ° | In distribution |
| 100114836 | Width 14 mm | In distribution |
| 100112832 | Angle 8 ° | In distribution |
| 100116022 | Width 16 mm | In distribution |
| 100112840 | Width 12 mm | In distribution |
| 100116046 | Width 16 mm | In distribution |
| 100114844 | Width 14 mm | In distribution |
| 100114832 | Angle 8 ° | In distribution |
| 100116030 | Width 16 mm | In distribution |
| 100112834 | Width 12 mm | In distribution |
| 100112848 | Width 12 mm | In distribution |
| 100114518 | Width 14 mm | In distribution |
| 100114528 | Angle 5 ° | In distribution |
| 100116050 | Width 16 mm | In distribution |
| 100112836 | Width 12 mm | In distribution |
| 100114840 | Width 14 mm | In distribution |
| 100114530 | Angle 5 ° | In distribution |
| 100116034 | Width 16 mm | In distribution |
| 100112530 | Angle 5 ° | In distribution |
| 100112844 | Width 12 mm | In distribution |
| 100112520 | Angle 5 ° | In distribution |
| 100112528 | Angle 5 ° | In distribution |
| 100112842 | Width 12 mm | In distribution |
| 100114846 | Width 14 mm | In distribution |
| 100116038 | Width 16 mm | In distribution |
| 100112524 | Angle 5 ° | In distribution |
| 100112846 | Width 12 mm | In distribution |
| 100112522 | Angle 5 ° | In distribution |
| 100114520 | Angle 5 ° | In distribution |
| 100116040 | Angle 0 ° | In distribution |
| 100116024 | Angle 0 ° | In distribution |
| 100112850 | Width 12 mm | In distribution |
| 100116026 | Width 16 mm | In distribution |
| 100114522 | Angle 5 ° | In distribution |
| 100112838 | Width 12 mm | In distribution |
| 100114848 | Width 14 mm | In distribution |
| 100114526 | Angle 5 ° | In distribution |
| 100114850 | Width 14 mm | In distribution |
| 100112526 | Angle 5 ° | In distribution |
| 100114842 | Width 14 mm | In distribution |
| 100116048 | Angle 0 ° | In distribution |
| 100116032 | Angle 0 ° | 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
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.