Zevo™ Anterior Cervical Plate System
Screw G7713514 Zevo VAR SD 3.5MM X 14MM
14manufacturers in China registered for this device type
570catalogue 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) | K141632 |
| Record published | 2025-05-03 |
| Record revised | 2022-09-16 (version 9) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Sizes | Length 15 to 89 mm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 3003049 | Length 49.0 mm | In distribution | |
| G3001023 | In distribution | ||
| 7713510 | In distribution | ||
| 3002048 | Length 48.0 mm | In distribution | |
| 7714015 | In distribution | ||
| G7713514 | 2 | In distribution | |
| 7724011 | In distribution | ||
| G7703513 | In distribution | ||
| 7723520 | In distribution | ||
| 3003068 | In distribution | ||
| 3003055 | In distribution | ||
| G3002027 | In distribution | ||
| G3001025 | In distribution | ||
| 7714015 | In distribution | ||
| G7783516 | In distribution | ||
| G7713515 | 2 | In distribution | |
| 3036017 | In distribution | ||
| G7724022 | In distribution | ||
| G7723516 | 2 | In distribution | |
| 3004079 | In distribution | ||
| G3003057 | In distribution | ||
| 7724018 | In distribution | ||
| G7713511 | 2 | In distribution | |
| G7713513 | 2 | In distribution | |
| G3001025 | In distribution | ||
| G7783517 | In distribution | ||
| G7714023 | In distribution | ||
| G7703522 | In distribution | ||
| G3005105 | In distribution | ||
| 3003047 | Length 47.0 mm | In distribution | |
| G7714023 | In distribution | ||
| 7724024 | In distribution | ||
| G7783512 | In distribution | ||
| 3004065 | Length 65.0 mm | In distribution | |
| G7713521 | 2 | In distribution | |
| G7713523 | 2 | In distribution | |
| 3004069 | In distribution | ||
| 7714014 | In distribution | ||
| G7723518 | 2 | In distribution | |
| G7713519 | 2 | In distribution | |
| G7713516 | 2 | In distribution | |
| G7724017 | In distribution | ||
| 7724015 | In distribution | ||
| G7723515 | 2 | In distribution | |
| 3003051 | In distribution | ||
| 7714017 | In distribution | ||
| 3003049 | In distribution | ||
| G7713521 | 2 | In distribution | |
| G7703520 | In distribution | ||
| 7723510 | In distribution | ||
| 3004086 | In distribution | ||
| 3001027 | Length 27.0 mm | In distribution | |
| G7714016 | In distribution | ||
| 7723519 | In distribution | ||
| G3003069 | In distribution | ||
| 7713516 | In distribution | ||
| G7723516 | 2 | In distribution | |
| 7724023 | In distribution | ||
| G3004065 | In distribution | ||
| 7714024 | In distribution | ||
| 3003067 | In distribution | ||
| 3002047 | Length 47.0 mm | In distribution | |
| 7713510 | In distribution | ||
| G7703517 | In distribution | ||
| 7713523 | In distribution | ||
| 7724022 | In distribution | ||
| 7724013 | In distribution | ||
| 7713516 | In distribution | ||
| 7713515 | In distribution | ||
| 7723517 | In distribution | ||
| G7713513 | 2 | In distribution | |
| 7714018 | In distribution | ||
| G7714019 | In distribution | ||
| G3002043 | In distribution | ||
| 7714022 | In distribution | ||
| G3002045 | In distribution | ||
| 7713522 | In distribution | ||
| 7714011 | In distribution | ||
| G7713512 | 2 | In distribution | |
| G3005079 | In distribution | ||
| 7724010 | In distribution | ||
| G3002035 | In distribution | ||
| 3036014 | In distribution | ||
| G7714013 | In distribution | ||
| G3002029 | In distribution | ||
| 7724016 | In distribution | ||
| G7724020 | In distribution | ||
| G7783510 | In distribution | ||
| G7724015 | In distribution | ||
| 7724021 | In distribution | ||
| G3004079 | In distribution | ||
| G7710015 | In distribution | ||
| 7710013 | In distribution | ||
| G3004077 | In distribution | ||
| 3004078 | Length 78.0 mm | In distribution | |
| G7724015 | In distribution | ||
| 3003068 | Length 68.0 mm | In distribution | |
| G3001019 | In distribution | ||
| G3002033 | In distribution | ||
| 3036015 | In distribution | ||
| 7714012 | In distribution | ||
| G3004087 | In distribution | ||
| 3001017 | Length 17.0 mm | In distribution | |
| G3002031 | In distribution | ||
| 3036013 | In distribution | ||
| G7723522 | 2 | In distribution | |
| G7724024 | In distribution | ||
| G7724023 | In distribution | ||
| 7723511 | In distribution | ||
| 3003057 | Length 57.0 mm | In distribution | |
| 3001023 | In distribution | ||
| 3005090 | In distribution | ||
| 7714014 | In distribution | ||
| G3003063 | Length 63.0 mm | In distribution | |
| 7724020 | In distribution | ||
| 7713518 | In distribution | ||
| G3003051 | In distribution | ||
| G7783515 | In distribution | ||
| G3002053 | In distribution | ||
| 7724020 | In distribution | ||
| G7713519 | 2 | In distribution | |
| G3002041 | In distribution | ||
| G7783518 | In distribution | ||
| G7724022 | In distribution | ||
| 3003048 | Length 48.0 mm | In distribution | |
| G3004067 | In distribution | ||
| G7783521 | In distribution | ||
| G7714012 | In distribution | ||
| G3003045 | In distribution | ||
| 3003059 | In distribution | ||
| G3004071 | In distribution | ||
| G7783514 | In distribution | ||
| G3003063 | In distribution | ||
| 7724021 | In distribution | ||
| G7724014 | In distribution | ||
| G7723522 | 2 | In distribution | |
| 3003061 | Length 61.0 mm | In distribution | |
| G7703524 | In distribution | ||
| 3003069 | Length 69.0 mm | In distribution | |
| G7714012 | In distribution | ||
| G7714018 | In distribution | ||
| G3003061 | In distribution | ||
| 7723524 | In distribution | ||
| G3002051 | In distribution | ||
| G3005108 | In distribution | ||
| G7724019 | In distribution | ||
| 3003055 | In distribution | ||
| 3004065 | In distribution | ||
| G3004067 | In distribution | ||
| G7724023 | In distribution | ||
| G7713517 | 2 | In distribution | |
| G7724016 | In distribution | ||
| G7703521 | In distribution | ||
| 7713517 | In distribution | ||
| 3002051 | Length 51.0 mm | In distribution | |
| G7713523 | 2 | In distribution | |
| 3001025 | In distribution | ||
| 3004079 | Length 79.0 mm | In distribution | |
| 3004087 | In distribution | ||
| 7713514 | In distribution | ||
| G7724024 | In distribution | ||
| G7703510 | In distribution | ||
| G3005100 | In distribution | ||
| 3004087 | Length 87.0 mm | In distribution | |
| 7714021 | In distribution | ||
| G7714017 | In distribution | ||
| G7724020 | In distribution | ||
| G3002048 | In distribution | ||
| G3001029 | In distribution | ||
| 7714020 | In distribution | ||
| G7723517 | 2 | In distribution | |
| G3002047 | In distribution | ||
| G3002035 | In distribution | ||
| G3001023 | In distribution | ||
| 3036015R | In distribution | ||
| 3002031 | Length 31.0 mm | In distribution | |
| G7723514 | 2 | In distribution | |
| 3002037 | In distribution | ||
| G3001017 | In distribution | ||
| G7713510 | 2 | In distribution | |
| 3003065 | In distribution | ||
| G3001015 | In distribution | ||
| G7783510 | In distribution | ||
| G7723521 | 2 | In distribution | |
| G3003057 | In distribution | ||
| 3004073 | Length 73.0 mm | In distribution | |
| G7723524 | 2 | In distribution | |
| G7703511 | In distribution | ||
| G7714014 | In distribution | ||
| 3002029 | In distribution | ||
| G3004075 | In distribution | ||
| G3003061 | Length 61.0 mm | In distribution | |
| G7714021 | In distribution | ||
| G7723523 | 2 | In distribution | |
| G3002033 | In distribution | ||
| 7714019 | In distribution | ||
| G3005081 | In distribution | ||
| G7723511 | 2 | In distribution | |
| G7723524 | 2 | In distribution | |
| G3002031 | In distribution | ||
| G3002053 | In distribution | ||
| 7713524 | In distribution | ||
| 3002035 | In distribution | ||
| 7713522 | In distribution | ||
| G7714010 | In distribution | ||
| G3003048 | In distribution | ||
| 7723512 | In distribution | ||
| G3002029 | In distribution | ||
| G3005085 | In distribution | ||
| G7783524 | In distribution | ||
| 3004078 | In distribution | ||
| 7723523 | In distribution | ||
| G7723517 | 2 | In distribution | |
| 7714023 | In distribution | ||
| G7713520 | 2 | In distribution | |
| 7713515 | In distribution | ||
| G7724021 | In distribution | ||
| G7703518 | In distribution | ||
| G3003068 | In distribution | ||
| G7723512 | 2 | In distribution | |
| G7783511 | In distribution | ||
| 3003071 | Length 71.0 mm | In distribution | |
| G3002049 | In distribution | ||
| G7724011 | In distribution | ||
| G3001027 | In distribution | ||
| 3003053 | In distribution | ||
| 3004067 | In distribution | ||
| G3004071 | In distribution | ||
| G7783521 | In distribution | ||
| G3004085 | In distribution | ||
| 7724018 | In distribution | ||
| G3003071 | In distribution | ||
| G3004086 | In distribution | ||
| G3004073 | In distribution | ||
| G7723519 | 2 | In distribution | |
| 7724019 | In distribution | ||
| 7723515 | In distribution | ||
| 3002029 | Length 29.0 mm | In distribution | |
| G7724010 | In distribution | ||
| G7703516 | In distribution | ||
| 3003067 | Length 67.0 mm | In distribution | |
| G7714015 | In distribution | ||
| 7714016 | In distribution | ||
| G7703511 | In distribution | ||
| G7783520 | In distribution | ||
| 7723522 | In distribution | ||
| G7723515 | 2 | In distribution | |
| 7714011 | In distribution | ||
| G7723514 | 2 | In distribution | |
| G7723518 | 2 | In distribution |
Showing 250 of 300 catalogue numbers.
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
1 recall names this product by its own identifier, 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 | 2018-03-23 | Class II | Process control | Slot screw had an overall length of 15mm, but per the specification, the screw should have an overall length of approximately 17mm. | 39 units | 2021-07-25 |
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.