Unify
UNIFY Dynamic Anterior Cervical Plate, Extra Lordotic 5-Level, 104mm
14manufacturers in China registered for this device type
224catalogue 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) | K121049 |
| Record published | 2015-11-06 |
| 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 4.6 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 197.128 | Length 28 mm | In distribution |
| 197.343 | Length 43 mm | In distribution |
| 197.236 | Length 36 mm | In distribution |
| 197.615 | Length 15 mm | In distribution |
| 197.534 | Length 14 mm | In distribution |
| 197.924 | Length 24 mm | In distribution |
| 597.910 | Outer Diameter 4.6 mm | In distribution |
| 197.920 | Length 20 mm | In distribution |
| 197.710 | Outer Diameter 4.6 mm | In distribution |
| 197.616 | Length 16 mm | In distribution |
| 197.810 | Outer Diameter 4.2 mm | In distribution |
| 597.340 | Length 40 mm | In distribution |
| 597.034 | Outer Diameter 4.2 mm | In distribution |
| 597.536 | Length 16 mm | In distribution |
| 197.013 | Length 13 mm | In distribution |
| 197.492 | Length 92 mm | In distribution |
| 597.355 | Length 55 mm | In distribution |
| 197.484 | Length 84 mm | In distribution |
| 197.820 | Outer Diameter 4.2 mm | In distribution |
| 597.124 | Length 24 mm | In distribution |
| 597.530 | Length 10 mm | In distribution |
| 197.116 | Length 16 mm | In distribution |
| 597.604 | Length 104 mm | In distribution |
| 197.604 | Length 104 mm | In distribution |
| 197.824 | Length 24 mm | In distribution |
| 597.484 | Length 84 mm | In distribution |
| 197.355 | Length 55 mm | In distribution |
| 597.496 | Length 96 mm | In distribution |
| 197.542 | Length 22 mm | In distribution |
| 597.122 | Length 22 mm | In distribution |
| 197.126 | Length 26 mm | In distribution |
| 597.364 | Length 64 mm | In distribution |
| 197.916 | Outer Diameter 4.6 mm | In distribution |
| 197.246 | Length 46 mm | In distribution |
| 597.812 | Outer Diameter 4.2 mm | In distribution |
| 197.513 | Outer Diameter 4.6 mm | In distribution |
| 597.230 | Length 30 mm | In distribution |
| 197.480 | Length 80 mm | In distribution |
| 597.512 | Outer Diameter 4.6 mm | In distribution |
| 197.913 | Outer Diameter 4.6 mm | In distribution |
| 597.012 | Length 12 mm | In distribution |
| 597.226 | Length 26 mm | In distribution |
| 197.826 | Outer Diameter 4.2 mm | In distribution |
| 197.911 | Length 11 mm | In distribution |
| 597.914 | Outer Diameter 4.6 mm | In distribution |
| 197.515 | Outer Diameter 4.6 mm | In distribution |
| 197.248 | Length 48 mm | In distribution |
| 597.246 | Length 46 mm | In distribution |
| 197.464 | Length 64 mm | In distribution |
| 197.818 | Length 18 mm | In distribution |
| 197.036 | Length 16 mm | In distribution |
| 197.364 | Length 64 mm | In distribution |
| 597.240 | Length 40 mm | In distribution |
| 597.337 | Length 37 mm | In distribution |
| 597.514 | Outer Diameter 4.6 mm | In distribution |
| 197.358 | Length 58 mm | In distribution |
| 597.601 | Length 101 mm | In distribution |
| 197.015 | Length 15 mm | In distribution |
| 197.046 | Outer Diameter 4.2 mm | In distribution |
| 197.918 | Outer Diameter 4.6 mm | In distribution |
| 597.112 | Length 12 mm | In distribution |
| 597.583 | Length 83 mm | In distribution |
| 197.531 | Length 11 mm | In distribution |
| 597.480 | Length 80 mm | In distribution |
| 197.540 | Length 20 mm | In distribution |
| 197.040 | Length 20 mm | In distribution |
| 197.580 | Length 80 mm | In distribution |
| 197.238 | Length 38 mm | In distribution |
| 597.343 | Length 43 mm | In distribution |
| 197.033 | Length 13 mm | In distribution |
| 597.492 | Length 92 mm | In distribution |
| 597.532 | Outer Diameter 4.6 mm | In distribution |
| 597.367 | Length 67 mm | In distribution |
| 197.713 | Length 13 mm | In distribution |
| 597.716 | Outer Diameter 4.6 mm | In distribution |
| 197.352 | Length 52 mm | In distribution |
| 197.595 | Length 95 mm | In distribution |
| 197.472 | Length 72 mm | In distribution |
| 197.598 | Length 98 mm | In distribution |
| 597.516 | Length 16 mm | In distribution |
| 197.589 | Length 89 mm | In distribution |
| 197.586 | Length 86 mm | In distribution |
| 597.814 | Outer Diameter 4.2 mm | In distribution |
| 197.124 | Length 24 mm | In distribution |
| 197.122 | Length 22 mm | In distribution |
| 597.616 | Length 16 mm | In distribution |
| 197.120 | Length 20 mm | In distribution |
| 597.361 | Length 61 mm | In distribution |
| 197.814 | Outer Diameter 4.2 mm | In distribution |
| 597.816 | Outer Diameter 4.2 mm | In distribution |
| 197.544 | Outer Diameter 4.6 mm | In distribution |
| 597.820 | Length 20 mm | In distribution |
| 197.716 | Length 16 mm | In distribution |
| 197.240 | Length 40 mm | In distribution |
| 197.030 | Length 10 mm | In distribution |
| 197.614 | Length 14 mm | In distribution |
| 597.592 | Length 92 mm | In distribution |
| 197.516 | Length 16 mm | In distribution |
| 197.714 | Length 14 mm | In distribution |
| 197.228 | Length 28 mm | In distribution |
| 597.476 | Length 76 mm | In distribution |
| 197.011 | Outer Diameter 4.2 mm | In distribution |
| 597.010 | Length 10 mm | In distribution |
| 197.592 | Length 92 mm | In distribution |
| 197.230 | Length 30 mm | In distribution |
| 197.010 | Length 10 mm | In distribution |
| 597.614 | Length 14 mm | In distribution |
| 197.014 | Length 14 mm | In distribution |
| 597.352 | Length 52 mm | In distribution |
| 197.476 | Length 76 mm | In distribution |
| 597.595 | Length 95 mm | In distribution |
| 197.112 | Length 12 mm | In distribution |
| 197.244 | Length 44 mm | In distribution |
| 597.014 | Outer Diameter 4.2 mm | In distribution |
| 197.915 | Length 15 mm | In distribution |
| 197.232 | Length 32 mm | In distribution |
| 197.926 | Outer Diameter 4.6 mm | In distribution |
| 197.530 | Outer Diameter 4.6 mm | In distribution |
| 197.242 | Length 42 mm | In distribution |
| 597.228 | Length 28 mm | In distribution |
| 197.032 | Length 12 mm | In distribution |
| 197.612 | Outer Diameter 4.2 mm | In distribution |
| 197.510 | Outer Diameter 4.6 mm | In distribution |
| 597.598 | Length 98 mm | In distribution |
| 597.126 | Length 26 mm | In distribution |
| 197.811 | Outer Diameter 4.2 mm | In distribution |
| 197.613 | Outer Diameter 4.2 mm | In distribution |
| 197.038 | Outer Diameter 4.2 mm | In distribution |
| 597.030 | Outer Diameter 4.2 mm | In distribution |
| 597.358 | Length 58 mm | In distribution |
| 597.036 | Outer Diameter 4.2 mm | In distribution |
| 197.500 | Length 100 mm | In distribution |
| 197.031 | Length 11 mm | In distribution |
| 597.538 | Outer Diameter 4.6 mm | In distribution |
| 597.580 | Length 80 mm | In distribution |
| 197.226 | Length 26 mm | In distribution |
| 597.589 | Length 89 mm | In distribution |
| 597.120 | Length 20 mm | In distribution |
| 197.535 | Length 15 mm | In distribution |
| 197.114 | Length 14 mm | In distribution |
| 597.818 | Length 18 mm | In distribution |
| 197.912 | Length 12 mm | In distribution |
| 197.822 | Outer Diameter 4.2 mm | In distribution |
| 597.234 | Length 34 mm | In distribution |
| 197.610 | Length 10 mm | In distribution |
| 597.038 | Outer Diameter 4.2 mm | In distribution |
| 597.534 | Outer Diameter 4.6 mm | In distribution |
| 197.034 | Outer Diameter 4.2 mm | In distribution |
| 197.711 | Length 11 mm | In distribution |
| 197.922 | Length 22 mm | In distribution |
| 597.510 | Length 10 mm | In distribution |
| 197.118 | Length 18 mm | In distribution |
| 197.536 | Length 16 mm | In distribution |
| 197.367 | Length 67 mm | In distribution |
| 597.612 | Outer Diameter 4.2 mm | In distribution |
| 597.016 | Length 16 mm | In distribution |
| 597.116 | Length 16 mm | In distribution |
| 197.044 | Length 24 mm | In distribution |
| 597.232 | Length 32 mm | In distribution |
| 197.042 | Length 22 mm | In distribution |
| 197.514 | Outer Diameter 4.6 mm | In distribution |
| 597.110 | Length 10 mm | In distribution |
| 197.583 | Length 83 mm | In distribution |
| 197.512 | Length 12 mm | In distribution |
| 197.234 | Length 34 mm | In distribution |
| 197.496 | Length 96 mm | In distribution |
| 197.460 | Length 60 mm | In distribution |
| 197.346 | Length 46 mm | In distribution |
| 197.012 | Outer Diameter 4.2 mm | In distribution |
| 597.349 | Length 49 mm | In distribution |
| 597.464 | Length 64 mm | In distribution |
| 597.918 | Outer Diameter 4.6 mm | In distribution |
| 597.248 | Length 48 mm | In distribution |
| 197.815 | Outer Diameter 4.2 mm | In distribution |
| 597.472 | Length 72 mm | In distribution |
| 197.349 | Length 49 mm | In distribution |
| 597.586 | Length 86 mm | In distribution |
| 597.128 | Length 28 mm | In distribution |
| 197.914 | Outer Diameter 4.6 mm | In distribution |
| 197.611 | Length 11 mm | In distribution |
| 597.114 | Length 14 mm | In distribution |
| 197.813 | Outer Diameter 4.2 mm | In distribution |
| 597.242 | Length 42 mm | In distribution |
| 597.920 | Length 20 mm | In distribution |
| 597.912 | Outer Diameter 4.6 mm | In distribution |
| 597.540 | Length 20 mm | In distribution |
| 197.812 | Length 12 mm | In distribution |
| 597.460 | Length 60 mm | In distribution |
| 197.816 | Outer Diameter 4.2 mm | In distribution |
| 597.370 | Length 70 mm | In distribution |
| 197.361 | Length 61 mm | In distribution |
| 597.040 | Outer Diameter 4.2 mm | In distribution |
| 597.500 | Length 100 mm | In distribution |
| 597.236 | Length 36 mm | In distribution |
| 597.346 | Length 46 mm | In distribution |
| 197.601 | Length 101 mm | In distribution |
| 197.488 | Length 88 mm | In distribution |
| 597.244 | Length 44 mm | In distribution |
| 197.715 | Length 15 mm | In distribution |
| 597.710 | Outer Diameter 4.6 mm | In distribution |
| 197.511 | Length 11 mm | In distribution |
| 597.488 | Length 88 mm | In distribution |
| 597.468 | Length 68 mm | In distribution |
| 197.337 | Length 37 mm | In distribution |
| 597.610 | Length 10 mm | In distribution |
| 597.810 | Outer Diameter 4.2 mm | In distribution |
| 597.238 | Length 38 mm | In distribution |
| 597.916 | Outer Diameter 4.6 mm | In distribution |
| 197.910 | Length 10 mm | In distribution |
| 197.546 | Outer Diameter 4.6 mm | In distribution |
| 197.538 | Outer Diameter 4.6 mm | In distribution |
| 197.340 | Length 40 mm | In distribution |
| 597.118 | Length 18 mm | In distribution |
| 197.468 | Length 68 mm | In distribution |
| 197.533 | Length 13 mm | In distribution |
| 197.035 | Length 15 mm | In distribution |
| 197.110 | Length 10 mm | In distribution |
| 597.712 | Length 12 mm | In distribution |
| 197.712 | Outer Diameter 4.6 mm | In distribution |
| 597.714 | Length 14 mm | In distribution |
| 197.016 | Outer Diameter 4.2 mm | In distribution |
| 197.370 | Length 70 mm | In distribution |
| 197.532 | Length 12 mm | In distribution |
| 597.032 | Length 12 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.