Struxxure® Anterior Cervical Plate System
Struxxure, Corpectomy Plate and Screw Caddy
14manufacturers in China registered for this device type
132catalogue numbers in this listing
3510(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 | Nexxt Spine LLC, United States |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K133475 |
| Record published | 2015-08-01 |
| Record revised | 2025-11-20 (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 | Length 10 to 115 mm; outer diameter 4 to 4.35 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 31-7-4020 | Outer Diameter 4 mm | In distribution |
| 31-5-95 | Length 95 mm | In distribution |
| 31-5-115 | Length 115 mm | In distribution |
| 31-7-4013 | Outer Diameter 4 mm | In distribution |
| 31-9-4315 | Outer Diameter 4.35 mm | In distribution |
| 31-1-36 | 1 Level | In distribution |
| 31-7-4012 | Outer Diameter 4 mm | In distribution |
| 31-7-4310 | Length 10 mm | In distribution |
| 31-6-4014 | Outer Diameter 4 mm | In distribution |
| 31-1-22 | Length 22 mm | In distribution |
| 31-8-4014 | Length 14 mm | In distribution |
| 31-9-4312 | Outer Diameter 4.35 mm | In distribution |
| 31-7-4318 | Length 18 mm | In distribution |
| 31-3-69 | Length 69 mm | In distribution |
| 31-3-57 | Length 57 mm | In distribution |
| 31-4-100 | Length 100 mm | In distribution |
| 31-5-75 | 5 Level | In distribution |
| 31-5-83 | 5 Level | In distribution |
| 31-6-4315 | Outer Diameter 4.35 mm | In distribution |
| 31-8-4312 | Length 12 mm | In distribution |
| 31-8-4310 | Outer Diameter 4.35 mm | In distribution |
| 31-4-72 | Length 72 mm | In distribution |
| 31-3-51 | Length 51 mm | In distribution |
| 31-1-26 | Length 26 mm | In distribution |
| 31-8-4313 | Length 13 mm | In distribution |
| 31-8-4017 | Outer Diameter 4 mm | In distribution |
| 31-7-4018 | Length 18 mm | In distribution |
| 31-9-4318 | Length 18 mm | In distribution |
| 31-6-4318 | Outer Diameter 4.35 mm | In distribution |
| 31-8-4011 | Outer Diameter 4 mm | In distribution |
| 31-9-4313 | Outer Diameter 4.35 mm | In distribution |
| 31-7-4316 | Outer Diameter 4.35 mm | In distribution |
| 31-5-91 | 5 Level | In distribution |
| 31-4-104 | 4 Level | In distribution |
| 31-2-52 | 2 Level | In distribution |
| 31-4-56 | Length 56 mm | In distribution |
| 31-7-4312 | Outer Diameter 4.35 mm | In distribution |
| 31-3-48 | 3 Level | In distribution |
| 31-1-28 | 1 Level | In distribution |
| 31-6-4313 | Outer Diameter 4.35 mm | In distribution |
| 31-6-4019 | Length 19 mm | In distribution |
| 31-5-79 | Length 79 mm | In distribution |
| 31-7-4313 | Outer Diameter 4.35 mm | In distribution |
| 31-5-67 | 5 Level | In distribution |
| 31-4-88 | Length 88 mm | In distribution |
| 31-4-76 | 4 Level | In distribution |
| 31-6-4015 | Length 15 mm | In distribution |
| 31-8-4013 | Outer Diameter 4 mm | In distribution |
| 31-9-4314 | Length 14 mm | In distribution |
| 31-8-4018 | Length 18 mm | In distribution |
| 31-1-32 | 1 Level | In distribution |
| 31-9-4016 | Outer Diameter 4 mm | In distribution |
| 31-4-64 | Length 64 mm | In distribution |
| 31-2-54 | Length 54 mm | In distribution |
| 31-7-4016 | Outer Diameter 4 mm | In distribution |
| 31-4-92 | 4 Level | In distribution |
| 31-1-17 | 1 Level | In distribution |
| 31-1-20 | 1 Level | In distribution |
| 31-5-71 | Length 71 mm | In distribution |
| 31-6-4017 | Length 17 mm | In distribution |
| 31-6-4013 | Length 13 mm | In distribution |
| 31-3-63 | Length 63 mm | In distribution |
| 31-4-84 | 4 Level | In distribution |
| 31-3-54 | 3 Level | In distribution |
| 31-4-68 | 4 Level | In distribution |
| 31-1-30 | Length 30 mm | In distribution |
| 31-2-34 | Length 34 mm | In distribution |
| 31-6-4011 | Length 11 mm | In distribution |
| 31-9-4010 | Length 10 mm | In distribution |
| 31-8-4015 | Outer Diameter 4 mm | In distribution |
| 31-6-4312 | Outer Diameter 4.35 mm | In distribution |
| 31-8-4315 | Length 15 mm | In distribution |
| 31-8-4012 | Length 12 mm | In distribution |
| 31-2-36 | 2 Level | In distribution |
| 31-8-4314 | Outer Diameter 4.35 mm | In distribution |
| 31-6-4012 | Outer Diameter 4 mm | In distribution |
| 31-4-80 | Length 80 mm | In distribution |
| 31-1-34 | Length 34 mm | In distribution |
| 31-7-4320 | Outer Diameter 4.35 mm | In distribution |
| 31-8-4019 | Outer Diameter 4 mm | In distribution |
| 31-2-46 | Length 46 mm | In distribution |
| 31-5-111 | 5 Level | In distribution |
| 31-6-4320 | Outer Diameter 4.35 mm | In distribution |
| 31-9-4014 | Length 14 mm | In distribution |
| 31-6-4316 | Outer Diameter 4.35 mm | In distribution |
| 31-2-50 | Length 50 mm | In distribution |
| 31-2-48 | 2 Level | In distribution |
| 31-6-4016 | Outer Diameter 4 mm | In distribution |
| 31-6-4018 | Outer Diameter 4 mm | In distribution |
| 31-9-4015 | Outer Diameter 4 mm | In distribution |
| 31-9-4013 | Length 13 mm | In distribution |
| 31-9-4320 | Outer Diameter 4.35 mm | In distribution |
| C31-53-01 | In distribution | |
| 31-9-4020 | Outer Diameter 4 mm | In distribution |
| 31-2-42 | Length 42 mm | In distribution |
| 31-9-4316 | Outer Diameter 4.35 mm | In distribution |
| 31-2-44 | 2 Level | In distribution |
| 31-6-4010 | Outer Diameter 4 mm | In distribution |
| 31-3-78 | 3 Level | In distribution |
| 31-8-4320 | Length 20 mm | In distribution |
| 31-4-96 | Length 96 mm | In distribution |
| 31-8-4010 | Length 10 mm | In distribution |
| 31-5-107 | Length 107 mm | In distribution |
| 31-6-4310 | Length 10 mm | In distribution |
| 31-3-66 | 3 Level | In distribution |
| 31-7-4315 | Outer Diameter 4.35 mm | In distribution |
| 31-9-4012 | Outer Diameter 4 mm | In distribution |
| 31-3-75 | Length 75 mm | In distribution |
| 31-9-4018 | Length 18 mm | In distribution |
| 31-8-4020 | Length 20 mm | In distribution |
| 31-7-4010 | Length 10 mm | In distribution |
| 31-6-4314 | Length 14 mm | In distribution |
| 31-8-4318 | Outer Diameter 4.35 mm | In distribution |
| 31-1-24 | 1 Level | In distribution |
| 31-5-103 | 5 Level | In distribution |
| 31-4-60 | 4 Level | In distribution |
| 31-1-18 | Length 18 mm | In distribution |
| C31-53-02 | In distribution | |
| 31-3-72 | 3 Level | In distribution |
| 31-7-4015 | Outer Diameter 4 mm | In distribution |
| 31-5-87 | Length 87 mm | In distribution |
| 31-7-4314 | Length 14 mm | In distribution |
| 31-3-60 | 3 Level | In distribution |
| 31-5-99 | 5 Level | In distribution |
| 31-9-4017 | Length 17 mm | In distribution |
| 31-7-4014 | Length 14 mm | In distribution |
| 31-8-4016 | Length 16 mm | In distribution |
| 31-6-4020 | Outer Diameter 4 mm | In distribution |
| 31-2-38 | Length 38 mm | In distribution |
| 31-8-4316 | Length 16 mm | In distribution |
| 31-2-40 | 2 Level | In distribution |
| 31-9-4310 | Length 10 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 |
|---|---|
| K240690 | 2024-03-22 |
| K202192 | 2020-09-17 |
| K133475 | 2013-12-19 |
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.