Silverstone Interbody Fusion System
30 x 10 x 11 mm, PEEK Silverstone-P
3manufacturers in China registered for this device type
75catalogue numbers in this listing
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 | Altus Spine, United States |
|---|---|
| FDA product code | MQP |
| Device type | Spinal Vertebral Body Replacement Device |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Record published | 2016-10-28 |
| Record revised | 2020-02-24 (version 3) |
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 |
| Sizes | Length 22 to 30 mm; height 6 to 18 mm; width 10 mm; angle 7 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PS-261015 | Length 26 mm | In distribution |
| SP301011 | Angle 7 ° | In distribution |
| PS-221011 | Width 10 mm | In distribution |
| SP221012 | Length 22 mm | In distribution |
| PS-221018 | Angle 7 ° | In distribution |
| SP221013 | Angle 7 ° | In distribution |
| PS-261008 | Height 8 mm | In distribution |
| SP221006 | Angle 7 ° | In distribution |
| SP261017 | Width 10 mm | In distribution |
| SP261010 | Angle 7 ° | In distribution |
| SP301015 | Height 15 mm | In distribution |
| SP261011 | Angle 7 ° | In distribution |
| PS-261010 | Length 26 mm | In distribution |
| PS-221017 | Angle 7 ° | In distribution |
| SP301017 | Width 10 mm | In distribution |
| PS-261014 | Angle 7 ° | In distribution |
| PS-221008 | Angle 7 ° | In distribution |
| SP301012 | Height 12 mm | In distribution |
| SP301016 | Length 30 mm | In distribution |
| SP301018 | Width 10 mm | In distribution |
| SP261006 | Length 26 mm | In distribution |
| PS-261013 | Angle 7 ° | In distribution |
| SP261018 | Width 10 mm | In distribution |
| PS-301010 | Angle 7 ° | In distribution |
| SP221014 | Length 22 mm | In distribution |
| SP221016 | Width 10 mm | In distribution |
| PS-301015 | Angle 7 ° | In distribution |
| PS-261016 | Angle 7 ° | In distribution |
| PS-301008 | Height 8 mm | In distribution |
| SP261015 | Length 26 mm | In distribution |
| SP301013 | Length 30 mm | In distribution |
| SP261007 | Length 26 mm | In distribution |
| PS-301013 | Angle 7 ° | In distribution |
| SP221007 | Height 7 mm | In distribution |
| SP261008 | Width 10 mm | In distribution |
| PS-301007 | Width 10 mm | In distribution |
| SP301010 | Width 10 mm | In distribution |
| PS-221014 | Length 22 mm | In distribution |
| PS-221016 | Height 16 mm | In distribution |
| PS-221010 | Length 22 mm | In distribution |
| PS-301011 | Length 30 mm | In distribution |
| PS-261007 | Angle 7 ° | In distribution |
| SP221015 | Length 22 mm | In distribution |
| PS-301017 | Length 30 mm | In distribution |
| SP221010 | Length 22 mm | In distribution |
| SP221018 | Length 22 mm | In distribution |
| SP221009 | Length 22 mm | In distribution |
| SP301014 | Angle 7 ° | In distribution |
| SP301009 | Length 30 mm | In distribution |
| PS-221015 | Length 22 mm | In distribution |
| SP221008 | Width 10 mm | In distribution |
| SP221011 | Length 22 mm | In distribution |
| PS-261017 | Width 10 mm | In distribution |
| SP261016 | Width 10 mm | In distribution |
| PS-301009 | Width 10 mm | In distribution |
| SP261013 | Length 26 mm | In distribution |
| SP301006 | Height 6 mm | In distribution |
| PS-261012 | Angle 7 ° | In distribution |
| PS-221012 | Length 22 mm | In distribution |
| PS-261018 | Height 18 mm | In distribution |
| SP221017 | Width 10 mm | In distribution |
| SP261014 | Length 26 mm | In distribution |
| PS-221009 | Angle 7 ° | In distribution |
| SP301007 | Length 30 mm | In distribution |
| SP261012 | Length 26 mm | In distribution |
| PS-221007 | Width 10 mm | In distribution |
| SP301008 | Angle 7 ° | In distribution |
| PS-301012 | Height 12 mm | In distribution |
| PS-301014 | Length 30 mm | In distribution |
| PS-301016 | Length 30 mm | In distribution |
| PS-301018 | Length 30 mm | In distribution |
| PS-261009 | Angle 7 ° | In distribution |
| PS-261011 | Length 26 mm | In distribution |
| SP261009 | Angle 7 ° | In distribution |
| PS-221013 | Width 10 mm | 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.