Sustain
SUSTAIN Radiolucent TPS Spacer, Oblique, Small, 10x22, 17mm
3manufacturers in China registered for this device type
228catalogue 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) | K143578 |
| Record published | 2020-03-08 |
| Record revised | 2025-07-14 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Sizes | Width 8 to 28 mm; height 5 to 21 mm; length 10 to 30 mm; depth 11 to 42 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 304.097CS | Length 22 mm | In distribution |
| 304.877CS | Height 17 mm | In distribution |
| 304.012CS | Height 12 mm | In distribution |
| 504.235 | Lordosis 7 Degree | In distribution |
| 304.385 | Depth 42 mm | In distribution |
| 304.932 | Height 12 mm | In distribution |
| 304.948 | Width 12 mm | In distribution |
| 101.415 | Width 25 mm | In distribution |
| 304.011CS | Height 11 mm | In distribution |
| 504.215 | Lordosis 7 Degree | In distribution |
| 304.084 | Width 8 mm | In distribution |
| 304.977CS | Height 17 mm | In distribution |
| 101.107 | Height 7 mm | In distribution |
| 101.711 | Height 11 mm | In distribution |
| 304.873CS | Height 13 mm | In distribution |
| 101.617 | Height 17 mm | In distribution |
| 304.088 | Height 8 mm | In distribution |
| 304.911 | Depth 11 mm | In distribution |
| 304.456 | Depth 31 mm | In distribution |
| 304.611 | Height 11 mm | In distribution |
| 101.226 | Width 14 mm | In distribution |
| 304.268 | Width 14 mm | In distribution |
| 304.097 | Width 10 mm | In distribution |
| 304.226 | Width 14 mm | In distribution |
| 101.849 | Width 12 mm | In distribution |
| 101.826 | Width 12 mm | In distribution |
| 101.245 | Height 5 mm | In distribution |
| 304.926 | Depth 11 mm | In distribution |
| 304.109 | Height 9 mm | In distribution |
| 101.847 | Width 12 mm | In distribution |
| 504.211 | Width 10 mm | In distribution |
| 304.814 | Width 10 mm | In distribution |
| 304.008 | Length 26 mm | In distribution |
| 304.352 | Lordosis 15 Degree | In distribution |
| 304.351 | Height 11 mm | In distribution |
| 304.929 | Lordosis 7 Degree | In distribution |
| 304.613 | Width 9.5 mm | In distribution |
| 304.068 | Depth 13 mm | In distribution |
| 304.912 | Height 12 mm | In distribution |
| 101.113 | Height 13 mm | In distribution |
| 304.084CS | Length 22 mm | In distribution |
| 101.613 | Height 13 mm | In distribution |
| 304.245 | Depth 13 mm | In distribution |
| 304.078 | Height 8 mm | In distribution |
| 304.117 | Width 10 mm | In distribution |
| 304.811CS | Length 30 mm | In distribution |
| 304.713 | Height 13 mm | In distribution |
| 304.208 | Depth 13 mm | In distribution |
| 101.615 | Width 9.5 mm | In distribution |
| 304.930 | Lordosis 7 Degree | In distribution |
| 304.873 | Width 12 mm | In distribution |
| 304.609 | Length 27 mm | In distribution |
| 304.083CS | Width 8 mm | In distribution |
| 304.081 | Length 22 mm | In distribution |
| 504.227 | Height 7 mm | In distribution |
| 101.611 | Height 11 mm | In distribution |
| 304.212 | Height 12 mm | In distribution |
| 304.017CS | Length 26 mm | In distribution |
| 304.275 | Lordosis 7 Degree | In distribution |
| 304.945 | Depth 11 mm | In distribution |
| 304.265 | Depth 13 mm | In distribution |
| 304.069 | Width 14 mm | In distribution |
| 101.225 | Lordosis 7 Degree | In distribution |
| 101.848 | Height 8 mm | In distribution |
| 504.216 | Lordosis 7 Degree | In distribution |
| 304.359 | Width 28 mm | In distribution |
| 304.281 | Lordosis 7 Degree | In distribution |
| 101.117 | Width 10 mm | In distribution |
| 304.615 | Length 27 mm | In distribution |
| 304.379 | Width 28 mm | In distribution |
| 304.812CS | Width 10 mm | In distribution |
| 304.908 | Width 12 mm | In distribution |
| 304.816CS | Height 16 mm | In distribution |
| 304.876 | Height 16 mm | In distribution |
| 101.851 | Height 11 mm | In distribution |
| 304.454 | Lordosis 4 Degree | In distribution |
| 101.251 | Depth 13 mm | In distribution |
| 304.971 | Width 12 mm | In distribution |
| 304.812 | Width 10 mm | In distribution |
| 304.086CS | Height 16 mm | In distribution |
| 304.311 | Width 25 mm | In distribution |
| 101.317 | Depth 31 mm | In distribution |
| 304.513 | Width 25 mm | In distribution |
| 304.107 | Width 10 mm | In distribution |
| 101.607 | Width 9.5 mm | In distribution |
| 304.816 | Height 16 mm | In distribution |
| 304.096 | Height 16 mm | In distribution |
| 304.165 | Width 10 mm | In distribution |
| 304.946 | Height 6 mm | In distribution |
| 304.872 | Height 12 mm | In distribution |
| 304.383 | Width 28 mm | In distribution |
| 304.976CS | Width 12 mm | In distribution |
| 304.815 | Height 15 mm | In distribution |
| 304.509 | Depth 31 mm | In distribution |
| 304.315 | Height 15 mm | In distribution |
| 101.421 | Height 21 mm | In distribution |
| 101.205 | Width 14 mm | In distribution |
| 304.279 | Width 14 mm | In distribution |
| 101.211 | Depth 13 mm | In distribution |
| 304.868CS | Width 12 mm | In distribution |
| 304.928 | Depth 11 mm | In distribution |
| 304.661 | Height 11 mm | In distribution |
| 101.825 | Depth 11 mm | In distribution |
| 304.269 | Height 9 mm | In distribution |
| 304.931 | Depth 11 mm | In distribution |
| 304.817 | Width 10 mm | In distribution |
| 504.212 | Height 12 mm | In distribution |
| 304.113 | Height 13 mm | In distribution |
| 304.870 | Width 12 mm | In distribution |
| 101.509 | Height 9 mm | In distribution |
| 304.267 | Width 14 mm | In distribution |
| 304.515 | Height 15 mm | In distribution |
| 304.907 | Depth 11 mm | In distribution |
| 304.016 | Length 26 mm | In distribution |
| 304.309 | Width 25 mm | In distribution |
| 304.715 | Width 8 mm | In distribution |
| 304.361 | Depth 42 mm | In distribution |
| 101.417 | Height 17 mm | In distribution |
| 304.808CS | Length 30 mm | In distribution |
| 101.411 | Height 11 mm | In distribution |
| 304.813CS | Height 13 mm | In distribution |
| 504.213 | Lordosis 7 Degree | In distribution |
| 504.231 | Width 10 mm | In distribution |
| 304.949 | Depth 11 mm | In distribution |
| 304.354 | Width 25 mm | In distribution |
| 304.814CS | Height 14 mm | In distribution |
| 304.411 | Width 25 mm | In distribution |
| 304.391 | Depth 42 mm | In distribution |
| 101.515 | Width 25 mm | In distribution |
| 101.715 | Length 22 mm | In distribution |
| 304.071 | Height 11 mm | In distribution |
| 304.271 | Width 14 mm | In distribution |
| 101.513 | Width 25 mm | In distribution |
| 304.951 | Height 11 mm | In distribution |
| 304.870CS | Width 12 mm | In distribution |
| 304.365 | Depth 42 mm | In distribution |
| 304.369 | Depth 42 mm | In distribution |
| 304.093 | Length 22 mm | In distribution |
| 504.234 | Lordosis 7 Degree | In distribution |
| 304.387 | Width 28 mm | In distribution |
| 504.236 | Length 26 mm | In distribution |
| 101.807 | Height 7 mm | In distribution |
| 304.080 | Width 8 mm | In distribution |
| 304.205 | Height 5 mm | In distribution |
| 101.208 | Depth 13 mm | In distribution |
| 304.657 | Length 30 mm | In distribution |
| 304.227 | Width 14 mm | In distribution |
| 101.829 | Lordosis 7 Degree | In distribution |
| 304.070 | Width 14 mm | In distribution |
| 304.081CS | Length 22 mm | In distribution |
| 304.419 | Depth 31 mm | In distribution |
| 304.876CS | Length 30 mm | In distribution |
| 504.208 | Height 8 mm | In distribution |
| 304.095CS | Length 22 mm | In distribution |
| 304.660 | Width 10 mm | In distribution |
| 304.065 | Width 14 mm | In distribution |
| 304.381 | Depth 42 mm | In distribution |
| 101.808 | Width 12 mm | In distribution |
| 101.717 | Width 8 mm | In distribution |
| 101.309 | Width 25 mm | In distribution |
| 304.875 | Length 30 mm | In distribution |
| 304.085 | Width 8 mm | In distribution |
| 304.927 | Width 12 mm | In distribution |
| 304.082 | Width 8 mm | In distribution |
| 304.875CS | Length 30 mm | In distribution |
| 304.415 | Depth 31 mm | In distribution |
| 304.014 | Height 14 mm | In distribution |
| 304.247 | Width 14 mm | In distribution |
| 304.969CS | Width 12 mm | In distribution |
| 304.009CS | Height 9 mm | In distribution |
| 304.246 | Depth 13 mm | In distribution |
| 304.910 | Height 10 mm | In distribution |
| 304.089 | Width 10 mm | In distribution |
| 304.251 | Depth 13 mm | In distribution |
| 304.012 | Length 26 mm | In distribution |
| 304.121 | Height 21 mm | In distribution |
| 304.211 | Depth 13 mm | In distribution |
| 304.717 | Length 22 mm | In distribution |
| 304.089CS | Width 10 mm | In distribution |
| 304.252 | Depth 13 mm | In distribution |
| 304.973 | Width 12 mm | In distribution |
| 101.315 | Width 25 mm | In distribution |
| 304.810CS | Width 10 mm | In distribution |
| 101.115 | Height 15 mm | In distribution |
| 304.086 | Width 8 mm | In distribution |
| 101.250 | Depth 13 mm | In distribution |
| 101.109 | Width 10 mm | In distribution |
| 304.250 | Depth 13 mm | In distribution |
| 101.311 | Depth 31 mm | In distribution |
| 304.278 | Depth 13 mm | In distribution |
| 304.093CS | Height 13 mm | In distribution |
| 101.846 | Width 12 mm | In distribution |
| 101.231 | Height 11 mm | In distribution |
| 304.091 | Height 11 mm | In distribution |
| 304.321 | Height 21 mm | In distribution |
| 304.409 | Depth 31 mm | In distribution |
| 304.225 | Lordosis 7 Degree | In distribution |
| 304.013 | Width 10 mm | In distribution |
| 304.811 | Width 10 mm | In distribution |
| 304.207 | Height 7 mm | In distribution |
| 304.709 | Width 8 mm | In distribution |
| 101.247 | Height 7 mm | In distribution |
| 304.008CS | Width 10 mm | In distribution |
| 304.248 | Depth 13 mm | In distribution |
| 304.413 | Height 13 mm | In distribution |
| 304.977 | Width 12 mm | In distribution |
| 304.972 | Length 26 mm | In distribution |
| 304.017 | Width 10 mm | In distribution |
| 101.228 | Lordosis 7 Degree | In distribution |
| 304.517 | Width 25 mm | In distribution |
| 304.974 | Length 26 mm | In distribution |
| 304.272 | Height 12 mm | In distribution |
| 504.230 | Height 10 mm | In distribution |
| 304.209 | Width 14 mm | In distribution |
| 304.355 | Depth 31 mm | In distribution |
| 304.010CS | Height 10 mm | In distribution |
| 304.817CS | Height 17 mm | In distribution |
| 304.096CS | Height 16 mm | In distribution |
| 304.659 | Height 9 mm | In distribution |
| 304.455 | Depth 31 mm | In distribution |
| 304.968 | Width 12 mm | In distribution |
| 304.014CS | Height 14 mm | In distribution |
| 304.664 | Width 10 mm | In distribution |
| 304.266 | Width 14 mm | In distribution |
| 304.371 | Depth 42 mm | In distribution |
| 304.974CS | Height 14 mm | In distribution |
| 101.830 | Depth 11 mm | In distribution |
| 101.828 | Lordosis 7 Degree | 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.