Vusion PS
10 mm 12 Degree Lordotic
3manufacturers in China registered for this device type
69catalogue numbers in this listing
1510(k) clearance
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 | Ortho Development Corp., 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, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K062666 |
| Record published | 2015-08-31 |
| Record revised | 2023-08-17 (version 4) |
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 | Height 6 to 18 mm; angle 6 to 12 ° |
| Distribution end date | 2023-08-08 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 551-5313 | Angle 6 ° | Withdrawn |
| 551-5308 | Angle 6 ° | Withdrawn |
| 551-5211 | Angle 6 ° | Withdrawn |
| 551-2114 | Height 14 mm | Withdrawn |
| 551-5318 | Angle 6 ° | Withdrawn |
| 551-5409 | Angle 12 ° | Withdrawn |
| 551-5115 | Height 15 mm | Withdrawn |
| 551-3110 | Height 10 mm | Withdrawn |
| 551-2110 | Angle 6 ° | Withdrawn |
| 551-5109 | Height 9 mm | Withdrawn |
| 551-5108 | Height 8 mm | Withdrawn |
| 551-5207 | Angle 6 ° | Withdrawn |
| 551-5408 | Angle 12 ° | Withdrawn |
| 551-5112 | Height 12 mm | Withdrawn |
| 551-5113 | Height 13 mm | Withdrawn |
| 551-2014 | Height 14 mm | Withdrawn |
| 551-2011 | Height 11 mm | Withdrawn |
| 551-5106 | Height 6 mm | Withdrawn |
| 551-2107 | Height 7 mm | Withdrawn |
| 551-5107 | Height 7 mm | Withdrawn |
| 551-3109 | Height 9 mm | Withdrawn |
| 551-5209 | Angle 6 ° | Withdrawn |
| 551-5213 | Height 13 mm | Withdrawn |
| 551-5309 | Angle 6 ° | Withdrawn |
| 551-5312 | Angle 6 ° | Withdrawn |
| 551-5118 | Height 18 mm | Withdrawn |
| 551-5214 | Height 14 mm | Withdrawn |
| 551-2007 | Height 7 mm | Withdrawn |
| 551-5410 | Height 10 mm | Withdrawn |
| 551-5412 | Height 12 mm | Withdrawn |
| 551-2112 | Height 12 mm | Withdrawn |
| 551-2106 | Height 6 mm | Withdrawn |
| 551-2013 | Height 13 mm | Withdrawn |
| 551-2111 | Angle 6 ° | Withdrawn |
| 551-5413 | Height 13 mm | Withdrawn |
| 551-2006 | Height 6 mm | Withdrawn |
| 551-5411 | Angle 12 ° | Withdrawn |
| 551-3108 | Height 8 mm | Withdrawn |
| 551-5218 | Angle 6 ° | Withdrawn |
| 551-5212 | Height 12 mm | Withdrawn |
| 551-5110 | Height 10 mm | Withdrawn |
| 551-3112 | Angle 12 ° | Withdrawn |
| 551-2108 | Angle 6 ° | Withdrawn |
| 551-5314 | Angle 6 ° | Withdrawn |
| 551-5310 | Angle 6 ° | Withdrawn |
| 551-5418 | Height 18 mm | Withdrawn |
| 551-2008 | Height 8 mm | Withdrawn |
| 551-5216 | Height 16 mm | Withdrawn |
| 551-5315 | Angle 6 ° | Withdrawn |
| 551-5311 | Height 11 mm | Withdrawn |
| 551-5215 | Height 15 mm | Withdrawn |
| 551-5111 | Height 11 mm | Withdrawn |
| 551-5416 | Angle 12 ° | Withdrawn |
| 551-5208 | Height 8 mm | Withdrawn |
| 551-5210 | Angle 6 ° | Withdrawn |
| 551-2113 | Angle 6 ° | Withdrawn |
| 551-3113 | Angle 12 ° | Withdrawn |
| 551-5316 | Angle 6 ° | Withdrawn |
| 551-5307 | Height 7 mm | Withdrawn |
| 551-2012 | Height 12 mm | Withdrawn |
| 551-2009 | Height 9 mm | Withdrawn |
| 551-2010 | Height 10 mm | Withdrawn |
| 551-5414 | Angle 12 ° | Withdrawn |
| 551-5116 | Height 16 mm | Withdrawn |
| 551-2109 | Angle 6 ° | Withdrawn |
| 551-3111 | Height 11 mm | Withdrawn |
| 551-5114 | Height 14 mm | Withdrawn |
| 551-3114 | Height 14 mm | Withdrawn |
| 551-5415 | Height 15 mm | Withdrawn |
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 |
|---|---|
| K062666 | 2007-01-25 |
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.