Anodyne Plate System
Anodyne-Single Cervical Screw - Variable Self Drilling - 5.2MM X 16MM
14manufacturers in China registered for this device type
178catalogue numbers in this listing
5510(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 | Corelink, LLC, United States |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Record published | 2016-01-21 |
| Record revised | 2025-07-02 (version 5) |
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 | Outer diameter 4 to 5.2 mm; length 12 to 20 mm; height 10 to 100 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 20140-18 | Outer Diameter 4 mm | In distribution |
| 20002-024 | Height 24 mm | In distribution |
| 20245-18 | Length 18 mm | In distribution |
| 20440-17 | Outer Diameter 4 mm | In distribution |
| 21452-16 | Length 16 mm | In distribution |
| 21001-018 | Height 18 mm | In distribution |
| 20440-16 | Outer Diameter 4 mm | In distribution |
| 20003-062 | Height 62 mm | In distribution |
| 20001-026 | Height 26 mm | In distribution |
| 21252-12 | Outer Diameter 5.2 mm | In distribution |
| 20440-18 | Outer Diameter 4 mm | In distribution |
| 21002-038 | Height 38 mm | In distribution |
| 20345-14 | Outer Diameter 4.5 mm | In distribution |
| 21352-18 | Length 18 mm | In distribution |
| 20002-046 | Height 46 mm | In distribution |
| 20240-20 | Outer Diameter 4 mm | In distribution |
| 20145-18 | Length 18 mm | In distribution |
| 20445-15 | Outer Diameter 4.5 mm | In distribution |
| 20001-010 | Height 10 mm | In distribution |
| 20002-032 | Height 32 mm | In distribution |
| 20345-20 | Length 20 mm | In distribution |
| 20004-060 | Height 60 mm | In distribution |
| 20001-024 | Height 24 mm | In distribution |
| 21002-034 | Height 34 mm | In distribution |
| 20002-026 | Height 26 mm | In distribution |
| 21346-12 | Length 12 mm | In distribution |
| 21152-16 | Outer Diameter 5.2 mm | In distribution |
| 20002-036 | Height 36 mm | In distribution |
| 21002-040 | Height 40 mm | In distribution |
| 21146-14 | Outer Diameter 4.6 mm | In distribution |
| 20445-13 | Length 13 mm | In distribution |
| 20445-17 | Outer Diameter 4.5 mm | In distribution |
| 20002-044 | Height 44 mm | In distribution |
| 20440-15 | Length 15 mm | In distribution |
| 20001-014 | Height 14 mm | In distribution |
| 20245-17 | Length 17 mm | In distribution |
| 20145-20 | Length 20 mm | In distribution |
| 20003-052 | Height 52 mm | In distribution |
| 20345-12 | Length 12 mm | In distribution |
| 21452-20 | Length 20 mm | In distribution |
| 20245-12 | Outer Diameter 4.5 mm | In distribution |
| 20145-16 | Length 16 mm | In distribution |
| 20440-13 | Outer Diameter 4 mm | In distribution |
| 20004-068 | Height 68 mm | In distribution |
| 20245-19 | Outer Diameter 4.5 mm | In distribution |
| 20445-19 | Length 19 mm | In distribution |
| 20245-13 | Length 13 mm | In distribution |
| 20001-028 | Height 28 mm | In distribution |
| 20445-20 | Length 20 mm | In distribution |
| 20440-20 | Length 20 mm | In distribution |
| 20003-046 | Height 46 mm | In distribution |
| 20340-20 | Length 20 mm | In distribution |
| 21001-022 | Height 22 mm | In distribution |
| 20445-18 | Length 18 mm | In distribution |
| 21146-20 | Outer Diameter 4.6 mm | In distribution |
| 21346-16 | Outer Diameter 4.6 mm | In distribution |
| 21252-18 | Outer Diameter 5.2 mm | In distribution |
| 20440-12 | Length 12 mm | In distribution |
| 20001-013 | Height 13 mm | In distribution |
| 20003-050 | Height 50 mm | In distribution |
| 20445-16 | Outer Diameter 4.5 mm | In distribution |
| 21446-16 | Outer Diameter 4.6 mm | In distribution |
| 20002-034 | Height 34 mm | In distribution |
| 21146-18 | Length 18 mm | In distribution |
| 21001-020 | Height 20 mm | In distribution |
| 20440-14 | Length 14 mm | In distribution |
| 20140-20 | Outer Diameter 4 mm | In distribution |
| 21446-12 | Length 12 mm | In distribution |
| 20240-17 | Outer Diameter 4 mm | In distribution |
| 20340-13 | Length 13 mm | In distribution |
| 20002-042 | Height 42 mm | In distribution |
| 21146-12 | Outer Diameter 4.6 mm | In distribution |
| 20245-16 | Length 16 mm | In distribution |
| 21246-12 | Length 12 mm | In distribution |
| 20345-15 | Outer Diameter 4.5 mm | In distribution |
| 20001-012 | Height 12 mm | In distribution |
| 21002-028 | Height 28 mm | In distribution |
| 20340-19 | Outer Diameter 4 mm | In distribution |
| 21246-14 | Outer Diameter 4.6 mm | In distribution |
| 21452-12 | Length 12 mm | In distribution |
| 20240-16 | Outer Diameter 4 mm | In distribution |
| 20345-16 | Length 16 mm | In distribution |
| 20340-15 | Outer Diameter 4 mm | In distribution |
| 21002-032 | Height 32 mm | In distribution |
| 20445-14 | Outer Diameter 4.5 mm | In distribution |
| 20240-15 | Length 15 mm | In distribution |
| 21446-14 | Outer Diameter 4.6 mm | In distribution |
| 21352-14 | Length 14 mm | In distribution |
| 20345-13 | Length 13 mm | In distribution |
| 20004-088 | Height 88 mm | In distribution |
| 20003-042 | Height 42 mm | In distribution |
| 20001-022 | Height 22 mm | In distribution |
| 20140-17 | Outer Diameter 4 mm | In distribution |
| 21446-20 | Length 20 mm | In distribution |
| 21002-026 | Height 26 mm | In distribution |
| 21152-18 | Outer Diameter 5.2 mm | In distribution |
| 21352-12 | Outer Diameter 5.2 mm | In distribution |
| 20002-040 | Height 40 mm | In distribution |
| 20140-16 | Length 16 mm | In distribution |
| 20001-011 | Height 11 mm | In distribution |
| 20004-064 | Height 64 mm | In distribution |
| 20145-15 | Length 15 mm | In distribution |
| 21152-20 | Length 20 mm | In distribution |
| 20001-016 | Height 16 mm | In distribution |
| 20340-12 | Length 12 mm | In distribution |
| 21446-18 | Length 18 mm | In distribution |
| 20140-14 | Length 14 mm | In distribution |
| 20240-14 | Outer Diameter 4 mm | In distribution |
| 21252-16 | Length 16 mm | In distribution |
| 21152-14 | Length 14 mm | In distribution |
| 20140-15 | Length 15 mm | In distribution |
| 20240-19 | Length 19 mm | In distribution |
| 20345-18 | Length 18 mm | In distribution |
| 20140-19 | Length 19 mm | In distribution |
| 20240-12 | Outer Diameter 4 mm | In distribution |
| 21346-18 | Outer Diameter 4.6 mm | In distribution |
| 20003-058 | Height 48 mm | In distribution |
| 20145-12 | Length 12 mm | In distribution |
| 20340-17 | Outer Diameter 4 mm | In distribution |
| 20345-19 | Outer Diameter 4.5 mm | In distribution |
| 21246-20 | Outer Diameter 4.6 mm | In distribution |
| 20240-18 | Length 18 mm | In distribution |
| 20001-020 | Height 20 mm | In distribution |
| 20145-17 | Outer Diameter 4.5 mm | In distribution |
| 20002-030 | Height 30 mm | In distribution |
| 20140-12 | Length 12 mm | In distribution |
| 21001-016 | Height 16 mm | In distribution |
| 20003-066 | Height 66 mm | In distribution |
| 20004-084 | Height 84 mm | In distribution |
| 21252-20 | Outer Diameter 5.2 mm | In distribution |
| 20001-018 | Height 18 mm | In distribution |
| 20345-17 | Outer Diameter 4.5 mm | In distribution |
| 20001-030 | Height 30 mm | In distribution |
| 21252-14 | Outer Diameter 5.2 mm | In distribution |
| 21152-12 | Length 12 mm | In distribution |
| 20145-13 | Outer Diameter 4.5 mm | In distribution |
| 21001-014 | Height 14 mm | In distribution |
| 20003-070 | Height 70 mm | In distribution |
| 20003-040 | Height 40 mm | In distribution |
| 20003-044 | Height 44 mm | In distribution |
| 20004-076 | Height 76 mm | In distribution |
| 20003-064 | Height 64 mm | In distribution |
| 20002-038 | Height 38 mm | In distribution |
| 20245-15 | Length 15 mm | In distribution |
| 20004-080 | Height 80 mm | In distribution |
| 20445-12 | Length 12 mm | In distribution |
| 21346-20 | Length 20 mm | In distribution |
| 20003-068 | Height 68 mm | In distribution |
| 20240-13 | Length 13 mm | In distribution |
| 21352-16 | Outer Diameter 5.2 mm | In distribution |
| 20003-048 | Height 48 mm | In distribution |
| 20004-072 | Height 72 mm | In distribution |
| 21246-18 | Outer Diameter 4.6 mm | In distribution |
| 21452-18 | Length 18 mm | In distribution |
| 20003-054 | Height 54 mm | In distribution |
| 20245-14 | Outer Diameter 4.5 mm | In distribution |
| 20004-096 | Height 96 mm | In distribution |
| 20003-056 | Height 56 mm | In distribution |
| 20440-19 | Length 19 mm | In distribution |
| 20002-028 | Height 28 mm | In distribution |
| 21452-14 | Outer Diameter 5.2 mm | In distribution |
| 20340-14 | Length 14 mm | In distribution |
| 20145-19 | Length 19 mm | In distribution |
| 20340-18 | Length 18 mm | In distribution |
| 20140-13 | Outer Diameter 4 mm | In distribution |
| 20004-092 | Height 92 mm | In distribution |
| 21146-16 | Outer Diameter 4.6 mm | In distribution |
| 20340-16 | Length 16 mm | In distribution |
| 21001-013 | Height 13 mm | In distribution |
| 21002-030 | Height 30 mm | In distribution |
| 20003-060 | Height 60 mm | In distribution |
| 21246-16 | Outer Diameter 4.6 mm | In distribution |
| 21346-14 | Length 14 mm | In distribution |
| 21002-036 | Height 36 mm | In distribution |
| 21352-20 | Length 20 mm | In distribution |
| 20004-100 | Height 100 mm | In distribution |
| 20145-14 | Outer Diameter 4.5 mm | In distribution |
| 20245-20 | Length 20 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 |
|---|---|
| K190016 | 2019-06-12 |
| K163104 | 2017-06-21 |
| K132994 | 2013-12-05 |
| K121514 | 2012-12-14 |
| K121791 | 2012-11-19 |
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.