Acura Stabilization System
ACURA Stabilization System 4.5 mm x 25 mm Polyaxial Screw
11manufacturers in China registered for this device type
22catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (5), Shandong (2), Shanghai (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| 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 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Indius Medical Technologies PVT. Ltd., India |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2022-03-01 |
| Record revised | 2024-09-11 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number |
| Sizes | Outer diameter 4 to 6.5 mm; length 20 to 55 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A004.0125 | Outer Diameter 4.5 mm | In distribution |
| A004.0040 | Outer Diameter 4.0 mm | In distribution |
| A004.0025 | Outer Diameter 4.0 mm | In distribution |
| A004.0330 | Outer Diameter 6.5 mm | In distribution |
| A004.0235 | Outer Diameter 5.5 mm | In distribution |
| A004.0355 | Outer Diameter 6.5 mm | In distribution |
| A004.0130 | Outer Diameter 4.5 mm | In distribution |
| A004.0245 | Outer Diameter 5.5 mm | In distribution |
| A004.0230 | Outer Diameter 5.5 mm | In distribution |
| A004.0350 | Outer Diameter 6.5 mm | In distribution |
| A004.0250 | Outer Diameter 5.5 mm | In distribution |
| A004.0335 | Outer Diameter 6.5 mm | In distribution |
| A004.0135 | Outer Diameter 4.5 mm | In distribution |
| A004.0240 | Outer Diameter 5.5 mm | In distribution |
| A004.0035 | Outer Diameter 4.0 mm | In distribution |
| A004.0030 | Outer Diameter 4.0 mm | In distribution |
| A004.0255 | Outer Diameter 5.5 mm | In distribution |
| A004.0345 | Outer Diameter 6.5 mm | In distribution |
| A004.0140 | Outer Diameter 4.5 mm | In distribution |
| A004.0020 | Outer Diameter 4.0 mm | In distribution |
| A004.0045 | Outer Diameter 4.0 mm | In distribution |
| A004.0340 | Outer Diameter 6.5 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Invictus | Alphatec Spine, Inc. | 5,422 |
| ReLine | Nuvasive, Inc. | 4,439 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,188 |
| Creo | Globus Medical, Inc. | 1,992 |
| Apex Spine System | Spinecraft LLC | 1,319 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 1,271 |
| Perla ® TL | Spineart SA | 1,035 |
| Astra Spine System | Spinecraft LLC | 1,003 |
| LineSider | Highridge Medical, LLC | 948 |
| Apex-DL Spine System | Spinecraft LLC | 909 |
| Revere | Globus Medical, Inc. | 875 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 841 |
Showing 12 of 536. All products under Appliance, Fixation, Spinal Interlaminal
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.