Xpand-R
XPand -R Corpectomy Spacer Medium-L 21x23/25x30, 0/3deg, 28-34mmS
3manufacturers in China registered for this device type
124catalogue numbers in this listing
11510(k) clearances naming this product code
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 | Globus Medical, Inc., United States |
|---|---|
| FDA product code | MQP |
| Device type | Spinal Vertebral Body Replacement Device |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K060665 |
| Record published | 2015-10-09 |
| Record revised | 2020-02-24 (version 4) |
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 |
| Sizes | Depth 13 to 25 mm; height 20 to 91 mm; width 15 to 30 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 316.127 | Depth 13 mm | In distribution |
| 316.012 | Depth 25 mm | In distribution |
| 316.518 | Height 36 mm | In distribution |
| 316.210 | Depth 21 mm | In distribution |
| 316.205 | Height 56 mm | In distribution |
| 316.009 | Sagittal Profile 8 Degree | In distribution |
| 316.117 | Height 32 mm | In distribution |
| 316.018 | Height 91 mm | In distribution |
| 316.007 | Sagittal Profile 8 Degree | In distribution |
| 316.405 | Depth 25 mm | In distribution |
| 316.202 | Height 34 mm | In distribution |
| 316.104 | Height 30 mm | In distribution |
| 316.501 | Width 26 mm | In distribution |
| 316.522 | Width 26 mm | In distribution |
| 316.509 | Width 26 mm | In distribution |
| 316.132 | Width 15 mm | In distribution |
| 316.011 | Sagittal Profile 16 Degree | In distribution |
| 316.122 | Width 15 mm | In distribution |
| 316.413 | Width 30 mm | In distribution |
| 316.404 | Width 30 mm | In distribution |
| 316.126 | Depth 13 mm | In distribution |
| 316.005 | Width 30 mm | In distribution |
| 316.204 | Height 46 mm | In distribution |
| 316.105 | Width 15 mm | In distribution |
| 316.102 | Width 15 mm | In distribution |
| 316.516 | Width 26 mm | In distribution |
| 316.206 | Sagittal Profile -6 Degree | In distribution |
| 316.221 | Depth 21 mm | In distribution |
| 316.201 | Width 23 mm | In distribution |
| 316.110 | Depth 13 mm | In distribution |
| 316.128 | Sagittal Profile 16 Degree | In distribution |
| 316.305 | Depth 21 mm | In distribution |
| 316.109 | Width 15 mm | In distribution |
| 316.120 | Sagittal Profile 7 Degree | In distribution |
| 316.207 | Width 23 mm | In distribution |
| 316.014 | Height 39 mm | In distribution |
| 316.506 | Width 26 mm | In distribution |
| 316.113 | Width 15 mm | In distribution |
| 316.517 | Sagittal Profile 16 Degree | In distribution |
| 316.107 | Height 44 mm | In distribution |
| 316.114 | Height 22 mm | In distribution |
| 316.111 | Width 15 mm | In distribution |
| 316.303 | Width 23 mm | In distribution |
| 316.508 | Width 26 mm | In distribution |
| 316.515 | Depth 23 mm | In distribution |
| 316.022 | Height 53 mm | In distribution |
| 316.119 | Height 44 mm | In distribution |
| 316.218 | Height 64 mm | In distribution |
| 316.302 | Height 24 mm | In distribution |
| 316.402 | Depth 25 mm | In distribution |
| 316.222 | Height 82 mm | In distribution |
| 316.220 | Sagittal Profile 8 Degree | In distribution |
| 316.010 | Sagittal Profile 8 Degree | In distribution |
| 316.118 | Width 15 mm | In distribution |
| 316.412 | Width 30 mm | In distribution |
| 316.507 | Width 26 mm | In distribution |
| 316.208 | Height 34 mm | In distribution |
| 316.514 | Height 64 mm | In distribution |
| 316.020 | Width 30 mm | In distribution |
| 316.407 | Width 30 mm | In distribution |
| 316.406 | Depth 25 mm | In distribution |
| 316.001 | Height 33 mm | In distribution |
| 316.112 | Height 80 mm | In distribution |
| 316.006 | Sagittal Profile 8 Degree | In distribution |
| 316.409 | Depth 25 mm | In distribution |
| 316.408 | Height 35 mm | In distribution |
| 316.214 | Sagittal Profile 8 Degree | In distribution |
| 316.026 | Width 30 mm | In distribution |
| 316.503 | Depth 23 mm | In distribution |
| 316.414 | Sagittal Profile 3 Degree | In distribution |
| 316.116 | Sagittal Profile 7 Degree | In distribution |
| 316.101 | Depth 13 mm | In distribution |
| 316.523 | Width 26 mm | In distribution |
| 316.125 | Height 56 mm | In distribution |
| 316.510 | Depth 23 mm | In distribution |
| 316.520 | Depth 23 mm | In distribution |
| 316.304 | Height 23 mm | In distribution |
| 316.003 | Height 45 mm | In distribution |
| 316.129 | Height 20 mm | In distribution |
| 316.212 | Depth 21 mm | In distribution |
| 316.013 | Width 30 mm | In distribution |
| 316.108 | Depth 13 mm | In distribution |
| 316.216 | Width 23 mm | In distribution |
| 316.505 | Height 56 mm | In distribution |
| 316.008 | Depth 25 mm | In distribution |
| 316.519 | Width 26 mm | In distribution |
| 316.021 | Height 45 mm | In distribution |
| 316.002 | Height 41 mm | In distribution |
| 316.219 | Sagittal Profile 8 Degree | In distribution |
| 316.025 | Height 33 mm | In distribution |
| 316.123 | Height 72 mm | In distribution |
| 316.502 | Depth 23 mm | In distribution |
| 316.524 | Width 26 mm | In distribution |
| 316.017 | Height 74 mm | In distribution |
| 316.130 | Width 15 mm | In distribution |
| 316.215 | Depth 21 mm | In distribution |
| 316.004 | Depth 25 mm | In distribution |
| 316.131 | Depth 13 mm | In distribution |
| 316.411 | Depth 25 mm | In distribution |
| 316.019 | Depth 25 mm | In distribution |
| 316.023 | Depth 25 mm | In distribution |
| 316.103 | Depth 13 mm | In distribution |
| 316.213 | Sagittal Profile 8 Degree | In distribution |
| 316.410 | Sagittal Profile 3 Degree | In distribution |
| 316.301 | Depth 21 mm | In distribution |
| 316.403 | Depth 25 mm | In distribution |
| 316.209 | Height 38 mm | In distribution |
| 316.015 | Depth 25 mm | In distribution |
| 316.511 | Height 38 mm | In distribution |
| 316.124 | Width 15 mm | In distribution |
| 316.513 | Depth 23 mm | In distribution |
| 316.521 | Depth 23 mm | In distribution |
| 316.027 | Depth 25 mm | In distribution |
| 316.211 | Width 23 mm | In distribution |
| 316.106 | Height 38 mm | In distribution |
| 316.504 | Height 46 mm | In distribution |
| 316.016 | Sagittal Profile 16 Degree | In distribution |
| 316.203 | Depth 21 mm | In distribution |
| 316.024 | Width 30 mm | In distribution |
| 316.217 | Width 23 mm | In distribution |
| 316.121 | Width 15 mm | In distribution |
| 316.115 | Height 28 mm | In distribution |
| 316.401 | Width 30 mm | In distribution |
| 316.512 | Depth 23 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K190147 | 2019-05-08 |
| K173982 | 2018-09-19 |
| K162315 | 2017-11-09 |
| K121107 | 2012-07-03 |
| K112756 | 2011-10-07 |
| K072465 | 2007-10-04 |
| K061380 | 2006-06-08 |
| K060665 | 2006-05-10 |
| K050850 | 2005-05-26 |
| K040284 | 2004-03-23 |
| K031302 | 2003-06-27 |
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.