Xtend
XTEND Anterior Cervical Plate, Universal Extender, Extra Lordotic, 1-Level, 12mm
14manufacturers in China registered for this device type
176catalogue numbers in this listing
15510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (2). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 14. All 14 manufacturers in China registered for Appliance, Fixation, Spinal Intervertebral Body
Record
| Listed by | Globus Medical, Inc., United States |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K092146 |
| Record published | 2015-11-07 |
| Record revised | 2025-11-20 (version 5) |
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 | Length 10 to 104 mm; outer diameter 4.2 to 5.1 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 161.616 | Outer Diameter 4.2 mm | In distribution |
| 161.012 | Outer Diameter 4.2 mm | In distribution |
| 561.134 | Length 14 mm | In distribution |
| 161.130 | Length 10 mm | In distribution |
| 561.430 | Length 30 mm | In distribution |
| 161.120 | Length 20 mm | In distribution |
| 161.315 | Length 15 mm | In distribution |
| 161.240 | Length 40 mm | In distribution |
| 161.118 | Length 18 mm | In distribution |
| 161.716 | Length 16 mm | In distribution |
| 161.369 | Length 69 mm | In distribution |
| 161.570 | Length 70 mm | In distribution |
| 161.234 | Length 34 mm | In distribution |
| 561.256 | Length 26 mm | In distribution |
| 161.238 | Length 38 mm | In distribution |
| 561.444 | Length 44 mm | In distribution |
| 561.314 | Length 14 mm | In distribution |
| 561.120 | Length 20 mm | In distribution |
| 161.317 | Outer Diameter 4.2 mm | In distribution |
| 561.224 | Length 24 mm | In distribution |
| 161.620 | Outer Diameter 4.2 mm | In distribution |
| 161.011 | Length 11 mm | In distribution |
| 561.226 | Length 26 mm | In distribution |
| 161.463 | Length 63 mm | In distribution |
| 561.438 | Length 38 mm | In distribution |
| 561.238 | Length 38 mm | In distribution |
| 161.951 | Outer Diameter 5.1 mm | In distribution |
| 561.242 | Length 42 mm | In distribution |
| 161.313 | Length 13 mm | In distribution |
| 161.126 | Length 26 mm | In distribution |
| 561.332 | Length 12 mm | In distribution |
| 161.610 | Length 10 mm | In distribution |
| 161.366 | Length 66 mm | In distribution |
| 161.232 | Length 32 mm | In distribution |
| 561.112 | Length 12 mm | In distribution |
| 161.010 | Outer Diameter 4.2 mm | In distribution |
| 561.132 | Length 12 mm | In distribution |
| 161.457 | Length 57 mm | In distribution |
| 561.228 | Length 28 mm | In distribution |
| 161.574 | Length 74 mm | In distribution |
| 161.020 | Length 20 mm | In distribution |
| 161.493 | Length 93 mm | In distribution |
| 561.432 | Length 32 mm | In distribution |
| 161.715 | Outer Diameter 4.2 mm | In distribution |
| 161.711 | Length 11 mm | In distribution |
| 561.234 | Length 34 mm | In distribution |
| 561.124 | Length 24 mm | In distribution |
| 161.228 | Length 28 mm | In distribution |
| 161.351 | Length 51 mm | In distribution |
| 161.718 | Length 18 mm | In distribution |
| 161.710 | Length 10 mm | In distribution |
| 161.583 | Length 83 mm | In distribution |
| 561.244 | Length 44 mm | In distribution |
| 161.345 | Length 45 mm | In distribution |
| 561.434 | Length 34 mm | In distribution |
| 561.440 | Length 40 mm | In distribution |
| 161.314 | Length 14 mm | In distribution |
| 561.118 | Length 18 mm | In distribution |
| 161.478 | Length 78 mm | In distribution |
| 561.326 | Length 26 mm | In distribution |
| 561.310 | Length 10 mm | In distribution |
| 161.363 | Length 63 mm | In distribution |
| 161.651 | Length 11 mm | In distribution |
| 161.712 | Length 12 mm | In distribution |
| 561.126 | Length 26 mm | In distribution |
| 161.354 | Length 54 mm | In distribution |
| 161.134 | Length 14 mm | In distribution |
| 161.320 | Outer Diameter 4.2 mm | In distribution |
| 161.379 | Length 39 mm | In distribution |
| 561.424 | Length 24 mm | In distribution |
| 161.618 | Outer Diameter 4.2 mm | In distribution |
| 161.460 | Length 60 mm | In distribution |
| 161.339 | Length 39 mm | In distribution |
| 561.436 | Length 36 mm | In distribution |
| 161.013 | Outer Diameter 4.2 mm | In distribution |
| 161.490 | Length 90 mm | In distribution |
| 561.254 | Length 24 mm | In distribution |
| 561.232 | Length 32 mm | In distribution |
| 161.321 | Length 21 mm | In distribution |
| 561.318 | Length 18 mm | In distribution |
| 161.342 | Length 42 mm | In distribution |
| 561.442 | Length 42 mm | In distribution |
| 161.254 | Length 24 mm | In distribution |
| 161.451 | Outer Diameter 5.1 mm | In distribution |
| 161.580 | Length 80 mm | In distribution |
| 161.016 | Outer Diameter 4.2 mm | In distribution |
| 161.601 | Length 101 mm | In distribution |
| 161.112 | Length 12 mm | In distribution |
| 161.132 | Length 12 mm | In distribution |
| 161.726 | Length 26 mm | In distribution |
| 161.720 | Outer Diameter 4.2 mm | In distribution |
| 561.236 | Length 36 mm | In distribution |
| 561.330 | Length 10 mm | In distribution |
| 161.244 | Length 44 mm | In distribution |
| 161.236 | Length 36 mm | In distribution |
| 161.015 | Length 15 mm | In distribution |
| 161.242 | Length 42 mm | In distribution |
| 161.357 | Length 57 mm | In distribution |
| 161.598 | Length 98 mm | In distribution |
| 561.426 | Length 26 mm | In distribution |
| 161.323 | Outer Diameter 4.2 mm | In distribution |
| 161.469 | Length 69 mm | In distribution |
| 561.456 | Length 26 mm | In distribution |
| 161.319 | Outer Diameter 4.2 mm | In distribution |
| 161.246 | Length 46 mm | In distribution |
| 161.312 | Length 12 mm | In distribution |
| 561.322 | Length 22 mm | In distribution |
| 561.312 | Length 12 mm | In distribution |
| 161.316 | Length 16 mm | In distribution |
| 161.466 | Length 66 mm | In distribution |
| 161.611 | Outer Diameter 4.2 mm | In distribution |
| 161.612 | Outer Diameter 4.2 mm | In distribution |
| 161.360 | Length 60 mm | In distribution |
| 161.751 | Length 11 mm | In distribution |
| 161.124 | Length 24 mm | In distribution |
| 161.589 | Length 89 mm | In distribution |
| 161.326 | Outer Diameter 4.2 mm | In distribution |
| 161.122 | Length 22 mm | In distribution |
| 561.116 | Length 16 mm | In distribution |
| 161.487 | Length 87 mm | In distribution |
| 561.428 | Length 28 mm | In distribution |
| 161.311 | Outer Diameter 4.2 mm | In distribution |
| 161.310 | Outer Diameter 4.2 mm | In distribution |
| 161.224 | Length 24 mm | In distribution |
| 161.615 | Length 15 mm | In distribution |
| 161.116 | Length 16 mm | In distribution |
| 161.613 | Outer Diameter 4.2 mm | In distribution |
| 161.714 | Length 14 mm | In distribution |
| 161.114 | Length 14 mm | In distribution |
| 561.454 | Length 24 mm | In distribution |
| 161.226 | Length 26 mm | In distribution |
| 161.230 | Length 30 mm | In distribution |
| 161.604 | Length 104 mm | In distribution |
| 161.617 | Length 17 mm | In distribution |
| 561.316 | Length 16 mm | In distribution |
| 161.256 | Length 26 mm | In distribution |
| 161.453 | Length 53 mm | In distribution |
| 161.586 | Length 86 mm | In distribution |
| 161.136 | Length 16 mm | In distribution |
| 561.130 | Length 10 mm | In distribution |
| 561.230 | Length 30 mm | In distribution |
| 161.722 | Length 22 mm | In distribution |
| 161.322 | Length 22 mm | In distribution |
| 561.246 | Length 46 mm | In distribution |
| 161.110 | Length 10 mm | In distribution |
| 161.595 | Length 95 mm | In distribution |
| 161.851 | Length 11 mm | In distribution |
| 161.318 | Outer Diameter 4.2 mm | In distribution |
| 561.122 | Length 22 mm | In distribution |
| 161.475 | Length 75 mm | In distribution |
| 161.018 | Outer Diameter 4.2 mm | In distribution |
| 561.446 | Length 46 mm | In distribution |
| 561.334 | Length 14 mm | In distribution |
| 161.484 | Length 84 mm | In distribution |
| 161.592 | Length 92 mm | In distribution |
| 161.325 | Outer Diameter 4.2 mm | In distribution |
| 561.320 | Length 20 mm | In distribution |
| 161.551 | Length 11 mm | In distribution |
| 161.481 | Length 81 mm | In distribution |
| 161.713 | Outer Diameter 4.2 mm | In distribution |
| 161.614 | Length 14 mm | In distribution |
| 161.258 | Length 28 mm | In distribution |
| 161.014 | Outer Diameter 4.2 mm | In distribution |
| 161.324 | Outer Diameter 4.2 mm | In distribution |
| 561.110 | Length 10 mm | In distribution |
| 161.019 | Length 19 mm | In distribution |
| 161.619 | Outer Diameter 4.2 mm | In distribution |
| 561.240 | Length 40 mm | In distribution |
| 161.577 | Length 77 mm | In distribution |
| 161.472 | Length 72 mm | In distribution |
| 161.251 | Outer Diameter 4.6 mm | In distribution |
| 561.114 | Length 14 mm | In distribution |
| 161.017 | Length 17 mm | In distribution |
| 161.724 | Length 24 mm | In distribution |
| 561.324 | Length 24 mm | In distribution |
| 161.348 | Length 48 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ReLine | Nuvasive, Inc. | 2,998 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,568 |
| Creo | Globus Medical, Inc. | 1,765 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 1,755 |
| Ozark Cervical Plate System | VB Spine LLC | 1,460 |
| Sirion | Astura Medical | 1,246 |
| Apex Spine System | Spinecraft LLC | 1,187 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 986 |
| Astra Spine System | Spinecraft LLC | 970 |
| Zavation | Zavation | 966 |
| ACP | Nuvasive, Inc. | 918 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 877 |
Showing 12 of 855. All products under Appliance, Fixation, Spinal Intervertebral Body
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233735 | 2024-01-25 |
| K232318 | 2023-10-31 |
| K192314 | 2019-10-23 |
| K183056 | 2019-04-19 |
| K181846 | 2018-11-06 |
| K133567 | 2014-02-20 |
| K121049 | 2012-06-27 |
| K120092 | 2012-04-13 |
| K092146 | 2009-11-16 |
| K092108 | 2009-08-13 |
| K081391 | 2008-07-03 |
| K070775 | 2007-04-19 |
| K062836 | 2006-12-19 |
| K062407 | 2006-09-06 |
| K040721 | 2004-06-17 |
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.