Acura Stabilization System
ACURA Stabilization System Ø 5.5 x 60 mm Cannulated Polyaxial Screw - NT
15manufacturers in China registered for this device type
60catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Shandong (3). 6 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 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| 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 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 15. All 15 manufacturers in China registered for Thoracolumbosacral Pedicle Screw System
Record
| Listed by | Indius Medical Technologies PVT. Ltd., India |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| 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 |
| Label carries | lot or batch number |
| Sizes | Outer diameter 4 to 10.5 mm; length 20 to 500 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A004.0445 | Outer Diameter 7.5 mm | In distribution |
| A004.2040 | Outer Diameter 5.5 mm | In distribution |
| A004.7030 | Outer Diameter 4.0 mm | In distribution |
| A004.7025 | Outer Diameter 4.0 mm | In distribution |
| A004.7040 | Outer Diameter 4.0 mm | In distribution |
| A004.2035 | Outer Diameter 5.5 mm | In distribution |
| A004.0440 | Outer Diameter 7.5 mm | In distribution |
| A004.2090 | Outer Diameter 5.5 mm | In distribution |
| A004.7790 | Outer Diameter 10.5 mm | In distribution |
| A004.0450 | Outer Diameter 7.5 mm | In distribution |
| A004.2055 | Outer Diameter 5.5 mm | In distribution |
| A004.2050 | Outer Diameter 5.5 mm | In distribution |
| A004.7685 | Outer Diameter 9.5 mm | In distribution |
| A004.2130 | Outer Diameter 5.5 mm | In distribution |
| A004.2075 | Outer Diameter 5.5 mm | In distribution |
| A004.3100 | Outer Diameter 5.5 mm | In distribution |
| A004.7020 | Outer Diameter 4.0 mm | In distribution |
| A004.3055 | Outer Diameter 5.5 mm | In distribution |
| A004.7260 | Outer Diameter 5.5 mm | In distribution |
| A004.7125 | Outer Diameter 4.5 mm | In distribution |
| A004.2070 | Outer Diameter 5.5 mm | In distribution |
| A004.2120 | Outer Diameter 5.5 mm | In distribution |
| A004.2045 | Outer Diameter 5.5 mm | In distribution |
| A004.7775 | Outer Diameter 10.5 mm | In distribution |
| A004.7700 | Outer Diameter 10.5 mm | In distribution |
| A004.2125 | Outer Diameter 5.5 mm | In distribution |
| A004.7675 | Outer Diameter 9.5 mm | In distribution |
| A004.0435 | Outer Diameter 7.5 mm | In distribution |
| A004.7770 | Outer Diameter 10.5 mm | In distribution |
| A004.2150 | Outer Diameter 5.5 mm | In distribution |
| A004.2095 | Outer Diameter 5.5 mm | In distribution |
| A004.0455 | Outer Diameter 7.5 mm | In distribution |
| A004.0360 | Outer Diameter 6.5 mm | In distribution |
| A004.7795 | Outer Diameter 10.5 mm | In distribution |
| A004.7565 | Outer Diameter 8.5 mm | In distribution |
| A004.7600 | Outer Diameter 9.5 mm | In distribution |
| A004.7780 | Outer Diameter 10.5 mm | In distribution |
| A004.2100 | Outer Diameter 5.5 mm | In distribution |
| A004.4000 | In distribution | |
| A004.2060 | Outer Diameter 5.5 mm | In distribution |
| A004.7695 | Outer Diameter 9.5 mm | In distribution |
| A004.2110 | Outer Diameter 5.5 mm | In distribution |
| A004.3045 | Outer Diameter 5.5 mm | In distribution |
| A004.7670 | Outer Diameter 9.5 mm | In distribution |
| A004.7330 | Outer Diameter 6.5 mm | In distribution |
| A004.7045 | Outer Diameter 4.0 mm | In distribution |
| A004.7785 | Outer Diameter 10.5 mm | In distribution |
| A004.2080 | Outer Diameter 5.5 mm | In distribution |
| A004.3065 | Outer Diameter 5.5 mm | In distribution |
| A004.2140 | Outer Diameter 5.5 mm | In distribution |
| A004.7690 | Outer Diameter 9.5 mm | In distribution |
| A004.2085 | Outer Diameter 5.5 mm | In distribution |
| A004.7560 | Outer Diameter 8.5 mm | In distribution |
| A004.3500 | Outer Diameter 5.5 mm | In distribution |
| A004.7035 | Outer Diameter 4.0 mm | In distribution |
| A004.7130 | Outer Diameter 4.5 mm | In distribution |
| A004.3075 | Outer Diameter 5.5 mm | In distribution |
| A004.2065 | Outer Diameter 5.5 mm | In distribution |
| A004.7680 | Outer Diameter 9.5 mm | In distribution |
| A004.3125 | Outer Diameter 5.5 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| The Jasper Spinal Fixation System | Gbs Commonwealth Co., Ltd. | 32,491 |
| Invictus | Alphatec Spine, Inc. | 4,722 |
| Vital Spinal Fixation System | Highridge Medical, LLC | 4,422 |
| Innoverse Spinal System | CG MedTech Co., Ltd. | 4,240 |
| 4CIS® Chiron Spinal Fixation System | Alpha AI Co., Ltd. | 3,787 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 3,522 |
| Hedjet System | Medyssey Co., Ltd. | 3,438 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 3,424 |
| Mega Plus MIS Spine System | BK Meditech Co., Ltd. | 3,396 |
| ReLine | Nuvasive, Inc. | 2,882 |
| Nex-D2 | Next Orthosurgical | 2,765 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2,386 |
Showing 12 of 1,490. All products under Thoracolumbosacral Pedicle Screw System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K200937 | 2020-10-26 |
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.