Zion
ACS, Self Drilling, Variable, 4.0MM-19MM
14manufacturers in China registered for this device type
94catalogue numbers in this listing
1510(k) clearance
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 | Astura Medical, 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) | K160702 |
| Record published | 2016-09-02 |
| Record revised | 2025-12-10 (version 10) |
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 | Length 10 to 244.97 mm; outer diameter 4 to 4.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CA2000044 | Level | In distribution |
| CBBB40016 | Outer Diameter 4.0 mm | In distribution |
| CA1000026 | Length 26 mm | In distribution |
| CBBB45010 | Outer Diameter 4.5 mm | In distribution |
| CA3000048 | Level | In distribution |
| CBBB45021 | Outer Diameter 4.5 mm | In distribution |
| CBAB40019 | Outer Diameter 4.0 mm | In distribution |
| CBAB40012 | Outer Diameter 4.0 mm | In distribution |
| CBAB40015 | Outer Diameter 4.0 mm | In distribution |
| CBAB40013 | Outer Diameter 4.0 mm | In distribution |
| CBBB40013 | Outer Diameter 4.0 mm | In distribution |
| CBBB45023 | Outer Diameter 4.5 mm | In distribution |
| CA3000051 | Level | In distribution |
| CA1000016 | LEVEL | In distribution |
| CA4000080 | 4 Level | In distribution |
| CA4000056 | Level | In distribution |
| CBBB45011 | Outer Diameter 4.5 mm | In distribution |
| CA3000039 | Level | In distribution |
| CBAB40016 | Outer Diameter 4.0 mm | In distribution |
| CA2000032 | Level | In distribution |
| CA3000057 | Level | In distribution |
| CA3000045 | Level | In distribution |
| CA1000012 | LEVEL | In distribution |
| CBBB45018 | Outer Diameter 4.5 mm | In distribution |
| CBBA40013 | Outer Diameter 4.0 mm | In distribution |
| CA3000060 | Level | In distribution |
| CBAB40018 | Outer Diameter 4.0 mm | In distribution |
| CBBB45022 | Outer Diameter 4.5 mm | In distribution |
| CBBB40017 | Outer Diameter 4.0 mm | In distribution |
| CA2000028 | Level | In distribution |
| CBBB45017 | Outer Diameter 4.5 mm | In distribution |
| CA3000042 | Level | In distribution |
| CBBA45010 | Outer Diameter 4.5 mm | In distribution |
| CBBA45018 | Outer Diameter 4.5 mm | In distribution |
| CA2000046 | Level | In distribution |
| CBBB40010 | Outer Diameter 4.0 mm | In distribution |
| CA1000014 | LEVEL | In distribution |
| CBBB40014 | Outer Diameter 4.0 mm | In distribution |
| CA4000064 | 4 Level | In distribution |
| CA1000010 | Levels | In distribution |
| CA4000068 | Length 68 mm | In distribution |
| CA4000072 | 4 Level | In distribution |
| CBBB40018 | Outer Diameter 4.0 mm | In distribution |
| CA1000020 | Level | In distribution |
| CA4000060 | 4 Level | In distribution |
| CA3000054 | Level | In distribution |
| CBBA45016 | Outer Diameter 4.5 mm | In distribution |
| CA2000024 | Level | In distribution |
| CBBB45015 | Outer Diameter 4.5 mm | In distribution |
| CBBA40015 | Outer Diameter 4.0 mm | In distribution |
| CBBB40012 | Outer Diameter 4.0 mm | In distribution |
| CBAB40017 | Outer Diameter 4.0 mm | In distribution |
| CBBA40017 | Outer Diameter 4.0 mm | In distribution |
| CA1000018 | level | In distribution |
| CBAB40011 | Outer Diameter 4.0 mm | In distribution |
| CBBB45024 | Outer Diameter 4.5 mm | In distribution |
| CBBB45019 | Outer Diameter 4.5 mm | In distribution |
| CBAB40020 | Outer Diameter 4.0 mm | In distribution |
| CZ0800020 | Double | In distribution |
| CA2000034 | Level | In distribution |
| CA1000024 | Level | In distribution |
| CBBB45013 | Outer Diameter 4.5 mm | In distribution |
| CA3000063 | Level | In distribution |
| CA4000076 | 4 Level | In distribution |
| CA2000026 | Level | In distribution |
| CBBB45016 | Outer Diameter 4.5 mm | In distribution |
| CBBB45014 | Outer Diameter 4.5 mm | In distribution |
| CBBB40020 | Outer Diameter 4.0 mm | In distribution |
| CA3000069 | Level | In distribution |
| CBBA45014 | Outer Diameter 4.5 mm | In distribution |
| CBBB40011 | Outer Diameter 4.0 mm | In distribution |
| CBBA40014 | Outer Diameter 4.0 mm | In distribution |
| CA2000030 | Level | In distribution |
| CA2000036 | Level | In distribution |
| CA1000022 | Level | In distribution |
| CBBA40011 | Outer Diameter 4.0 mm | In distribution |
| CBAB40014 | Outer Diameter 4.0 mm | In distribution |
| CA3000066 | Level | In distribution |
| CBBA40012 | Outer Diameter 4.0 mm | In distribution |
| CBBB45020 | Outer Diameter 4.5 mm | In distribution |
| CBBB40015 | Outer Diameter 4.0 mm | In distribution |
| CBBA45012 | Outer Diameter 4.5 mm | In distribution |
| CZ0800010 | Single | In distribution |
| CZ1300000 | Length 244.97 mm | In distribution |
| CBBB40019 | Outer Diameter 4.0 mm | In distribution |
| CZ1000040 | Outer Diameter 4.0 mm | In distribution |
| CBBB45012 | Outer Diameter 4.5 mm | In distribution |
| CBBA40010 | Outer Diameter 4.0 mm | In distribution |
| CA2000042 | Level | In distribution |
| CA2000040 | Level | In distribution |
| CBAB40010 | Outer Diameter 4.0 mm | In distribution |
| CA2000038 | Level | In distribution |
| CBBA40016 | Outer Diameter 4.0 mm | In distribution |
| CBBA40018 | Outer Diameter 4.0 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 |
|---|---|
| K160702 | 2016-08-23 |
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.