Atlantis(TM) Vision Anterior Cervical Plate
ATL VIS PLT-12/2-47.5MM-2LEV
14manufacturers in China registered for this device type
34catalogue numbers in this listing
20510(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 | Medtronic Sofamor Danek, Inc., United States |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| 510(k) | K021461 |
| Record published | 2015-08-19 |
| Record revised | 2025-11-20 (version 6) |
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 |
| Sizes | Width 19 to 110 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| X1002075 | Width 75.0 mm | In distribution |
| X1002027 | Width 27.0 mm | In distribution |
| X1002090 | Width 90.0 mm | In distribution |
| X1002047 | Width 47.5 mm | In distribution |
| X1002105 | Width 105.0 mm | In distribution |
| X1002085 | Width 85.0 mm | In distribution |
| X1002055 | Width 55.0 mm | In distribution |
| X1002021 | Width 21.0 mm | In distribution |
| X1002025 | Width 25.0 mm | In distribution |
| X1002037 | Width 37.5 mm | In distribution |
| X1002040 | Width 40.0 mm | In distribution |
| X1002032 | Width 32.5 mm | In distribution |
| X1002060 | Width 60.0 mm | In distribution |
| X1002072 | Width 72.5 mm | In distribution |
| X1002065 | Width 65.0 mm | In distribution |
| X1002080 | Width 80.0 mm | In distribution |
| X1002082 | Width 82.5 mm | In distribution |
| X1002100 | Width 100.0 mm | In distribution |
| X1002035 | Width 35.0 mm | In distribution |
| X1002030 | Width 30.0 mm | In distribution |
| X1002087 | Width 87.5 mm | In distribution |
| X1002077 | Width 77.5 mm | In distribution |
| X1002042 | Width 42.5 mm | In distribution |
| X1002050 | Width 50.0 mm | In distribution |
| X1002019 | Width 19.0 mm | In distribution |
| X1002067 | Width 67.5 mm | In distribution |
| X1002023 | Width 23.0 mm | In distribution |
| X1002062 | Width 62.5 mm | In distribution |
| X1002057 | Width 57.5 mm | In distribution |
| X1002110 | Width 110.0 mm | In distribution |
| X1002052 | Width 52.5 mm | In distribution |
| X1002095 | Width 95.0 mm | In distribution |
| X1002045 | Width 45.0 mm | In distribution |
| X1002070 | Width 70.0 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 |
|---|---|
| K140417 | 2014-07-09 |
| K081038 | 2008-08-15 |
| K063100 | 2007-02-23 |
| K061274 | 2006-05-25 |
| K050117 | 2005-02-17 |
| K043151 | 2005-02-01 |
| K031782 | 2005-02-01 |
| K042922 | 2004-11-19 |
| K042499 | 2004-10-07 |
| K042235 | 2004-09-17 |
| K042025 | 2004-08-25 |
| K041217 | 2004-05-28 |
| K040962 | 2004-05-14 |
| K032265 | 2003-08-11 |
| K030327 | 2003-02-26 |
| K021761 | 2002-09-17 |
| K021461 | 2002-07-22 |
| K021226 | 2002-05-13 |
| K013665 | 2002-01-29 |
| K994239 | 2000-06-19 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Medtronic Sofamor Danek USA, Inc. | 510(k) number | 2012-08-30 | Class II | Nonconforming Material/Component | Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws. An incorrect gauge could measure a screw to be approximately 1 mm shorter than its actual length. | 1047 units | 2013-08-15 |
| Medtronic Sofamor Danek USA, Inc. | 510(k) number | 2012-08-30 | Class II | Nonconforming Material/Component | Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws. An incorrect gauge could measure a screw to be approximately 1 mm shorter than its actual length. | 1014 units | 2013-08-15 |
| Medtronic Sofamor Danek USA, Inc. | 510(k) number | 2012-08-30 | Class II | Nonconforming Material/Component | Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws. An incorrect gauge could measure a screw to be approximately 1 mm shorter than its actual length. | 247 units | 2013-08-15 |
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.