Aranax Anterior Cervical Plating System
Ø4.00 VARIABLE SELF-DRILLING SCREW, 18 mm
14manufacturers in China registered for this device type
66catalogue numbers in this listing
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 | Xtant Medical Holdings, Inc., United States |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K150834 |
| Record published | 2015-12-09 |
| Record revised | 2025-12-24 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Length 9 to 95 mm; outer diameter 4 to 4.25 mm |
| Distribution end date | 2025-12-23 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| X086-1364-STR | Length 64 mm | Withdrawn | |
| X086-1257-STR | Length 68 mm | Withdrawn | |
| X086-1384-STR | Length 95 mm | Withdrawn | |
| X086-0002 | Withdrawn | ||
| X086-1712ST-STR | Outer Diameter 4.25 mm | 2 | Withdrawn |
| X086-1236-STR | Length 36 mm | Withdrawn | |
| X086-1015-STR | Length 26 mm | Withdrawn | |
| X086-1612SD-STR | Length 12 mm | 2 | Withdrawn |
| X086-1025-STR | Length 25 mm | Withdrawn | |
| X086-1143-STR | Length 43 mm | Withdrawn | |
| X086-1412ST-STR | Outer Diameter 4 mm | 2 | Withdrawn |
| X086-1368-STR | Length 68 mm | Withdrawn | |
| X086-1514ST-STR | Outer Diameter 4.25 mm | 2 | Withdrawn |
| X086-1352-STR | Length 63 mm | Withdrawn | |
| X086-1125-STR | Length 36 mm | Withdrawn | |
| X086-1618ST-STR | Outer Diameter 4 mm | 2 | Withdrawn |
| X086-1242-STR | Length 53 mm | Withdrawn | |
| X086-1011-STR | Length 11 mm | Withdrawn | |
| X086-1019-STR | Length 30 mm | Withdrawn | |
| X086-1009-STR | Length 20 mm | Withdrawn | |
| X086-1260-STR | Length 71 mm | Withdrawn | |
| X086-1239-STR | Length 39 mm | Withdrawn | |
| X086-1618SD-STR | Length 18 mm | 2 | Withdrawn |
| X086-1616ST-STR | Outer Diameter 4 mm | 2 | Withdrawn |
| X086-1372-STR | Length 72 mm | Withdrawn | |
| X086-1418SD-STR | Length 18 mm | 2 | Withdrawn |
| X086-1612ST-STR | Length 12 mm | 2 | Withdrawn |
| X086-1360-STR | Length 60 mm | Withdrawn | |
| X086-1614SD-STR | Outer Diameter 4 mm | 2 | Withdrawn |
| X086-1416SD-STR | Length 16 mm | 2 | Withdrawn |
| X086-1716ST-STR | Outer Diameter 4.25 mm | 2 | Withdrawn |
| X086-1251-STR | Length 62 mm | Withdrawn | |
| X086-1233-STR | Length 44 mm | Withdrawn | |
| X086-1266-STR | Length 77 mm | Withdrawn | |
| X086-1140-STR | Length 40 mm | Withdrawn | |
| X086-1512ST-STR | Outer Diameter 4.25 mm | 2 | Withdrawn |
| X086-1418ST-STR | Length 18 mm | 2 | Withdrawn |
| X086-1414SD-STR | Outer Diameter 4 mm | 2 | Withdrawn |
| X086-1017-STR | Length 28 mm | Withdrawn | |
| X086-1263-STR | Length 74 mm | Withdrawn | |
| X086-1344-STR | Length 44 mm | Withdrawn | |
| X086-1023-STR | Length 34 mm | Withdrawn | |
| X086-1614ST-STR | Outer Diameter 4 mm | 2 | Withdrawn |
| X086-1412SD-STR | Length 12 mm | 2 | Withdrawn |
| X086-1380-STR | Length 91 mm | Withdrawn | |
| X086-1131-STR | Length 31 mm | Withdrawn | |
| X086-1516ST-STR | Length 16 mm | 2 | Withdrawn |
| X086-1416ST-STR | Outer Diameter 4 mm | 2 | Withdrawn |
| X086-1122-STR | Length 33 mm | Withdrawn | |
| X086-1118-STR | Length 29 mm | Withdrawn | |
| X086-1518ST-STR | Length 18 mm | 2 | Withdrawn |
| X086-1376-STR | Length 76 mm | Withdrawn | |
| X086-1013-STR | Length 13 mm | Withdrawn | |
| X086-1348-STR | Length 48 mm | Withdrawn | |
| X086-1021-STR | Length 32 mm | Withdrawn | |
| X086-1248-STR | Length 59 mm | Withdrawn | |
| X086-1137-STR | Length 37 mm | Withdrawn | |
| X086-1414ST-STR | Length 14 mm | 2 | Withdrawn |
| X086-1254-STR | Length 65 mm | Withdrawn | |
| X086-1718ST-STR | Length 18 mm | 2 | Withdrawn |
| X086-1245-STR | Length 45 mm | Withdrawn | |
| X086-1714ST-STR | Length 14 mm | 2 | Withdrawn |
| X086-1134-STR | Length 45 mm | Withdrawn | |
| X086-1616SD-STR | Outer Diameter 4 mm | 2 | Withdrawn |
| X086-1128-STR | Length 28 mm | Withdrawn | |
| X086-1356-STR | Length 56 mm | Withdrawn |
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
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.