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Sign in to claim this brandWeigao Orthopaedic Device Co., Ltd.
US
Last updated May 23, 2026
What Weigao Orthopaedic Device Co., Ltd. makes
Weigao Orthopaedic Device Co., Ltd. manufactures orthopedic fixation systems, including anterior cervical plates for spinal stabilization, locking bone plates and screws for fracture fixation, and intramedullary nail systems for long bone alignment. Their portfolio also includes the Milestone Spinal System, designed for spinal surgical applications.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Weigao Orthopaedic Device Co., Ltd. manufacture?
Weigao Orthopaedic Device Co., Ltd. specializes in orthopedic fixation devices. Their product portfolio includes systems like anterior cervical plates for spinal stabilization, locking bone plates and screws for treating fractures, and intramedullary nail systems for aligning long bones. They also produce the Milestone Spinal System, which is intended for spinal surgical procedures. These devices are designed to support bone healing and structural integrity in orthopedic and spinal surgeries.
Where is Weigao Orthopaedic Device Co., Ltd. based?
Weigao Orthopaedic Device Co., Ltd. is based in the United States. While the company’s headquarters location isn’t specified, its devices are developed and marketed from within the U.S., where regulatory compliance—such as FDA clearance—applies.
Which regulatory registries or databases list Weigao Orthopaedic Device Co., Ltd.’s devices?
Weigao Orthopaedic Device Co., Ltd.’s devices are listed under the FDA’s 510(k) clearance records. This registry is used to demonstrate that their Class II orthopedic fixation systems meet regulatory requirements for safety and effectiveness before commercial distribution in the U.S. The 510(k) process ensures these devices are substantially equivalent to legally marketed predecessors.
How are Weigao Orthopaedic Device Co., Ltd.’s devices classified under FDA regulations?
Weigao Orthopaedic Device Co., Ltd.’s devices fall under Class II classification by the FDA. This classification applies to devices that pose moderate risk and require special controls—such as performance standards or post-market surveillance—to ensure safety and effectiveness. Since these devices are not invasive or life-supporting, they undergo a 510(k) premarket notification process to confirm compliance with regulatory standards.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (472)
Page 9 of 10| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Planar Screw | 8265035 | FDA UDI | Class II | Active |
| Fixed-Angle Screw | 8238065 | FDA UDI | Class II | Active |
| Planar Screw | 8265550 | FDA UDI | Class II | Active |
| Fixed-Angle Reduction Screw | 8248045 | FDA UDI | Class II | Active |
| Fixed-Angle Reduction Screw | 8248540 | FDA UDI | Class II | Active |
| Planar Screw | 8265525 | FDA UDI | Class II | Active |
| Iliac Screws | 803531085 | FDA UDI | Class II | Active |
| Straight Connection Rod | 803795140 | FDA UDI | Class II | Active |
| Crosslink A | 8482009 | FDA UDI | Class II | Active |
| Planar Reduction Screw | 803605035 | FDA UDI | Class II | Active |
| Iliac Screws | 803538075 | FDA UDI | Class II | Active |
| Multi-Axial Reduction Screw | 8228555 | FDA UDI | Class II | Active |
| Iliac Screws | 803538575 | FDA UDI | Class II | Active |
| Planar Reduction Screw | 803604525 | FDA UDI | Class II | Active |
| Curved Connection Rod | 803805090 | FDA UDI | Class II | Active |
| Iliac Screws | 803531065 | FDA UDI | Class II | Active |
| Planar Screw | 8266546 | FDA UDI | Class II | Active |
| Fixed-Angle Screw | 8236565 | FDA UDI | Class II | Active |
| Milestone Spinal System | 9300016 | FDA UDI | Class II | Active |
| Milestone Spinal System | 9300009 | FDA UDI | Class II | Active |
| Iliac Screws | 803539080 | FDA UDI | Class II | Active |
| Iliac Screws | 803539065 | FDA UDI | Class II | Active |
| Open Lateral Connector | 803835615 | FDA UDI | Class II | Active |
| Fixed-Angle Screw | 8238560 | FDA UDI | Class II | Unknown |
| Fixed-Angle Reduction Screw | 8248035 | FDA UDI | Class II | Unknown |
| Curved Connection Rod | 803805035 | FDA UDI | Class II | Active |
| Planar Screw | 8265555 | FDA UDI | Class II | Active |
| Planar Reduction Screw | 803606545 | FDA UDI | Class II | Active |
| Wide Pedicle Hook | 800460007 | FDA UDI | Class II | Active |
| Iliac Screws | 803539060 | FDA UDI | Class II | Active |
| Planar Reduction Screw | 803607030 | FDA UDI | Class II | Active |
| Planar Screw | 8267525 | FDA UDI | Class II | Active |
| Fixed-Angle Screw | 8238050 | FDA UDI | Class II | Unknown |
| Planar Screw | 8264528 | FDA UDI | Class II | Active |
| Iliac Screws | 803538085 | FDA UDI | Class II | Active |
| Milestone Spinal System | 9300006 | FDA UDI | Class II | Active |
| Straight Connection Rod | 803795065 | FDA UDI | Class II | Active |
| Straight Connection Rod | 803795075 | FDA UDI | Class II | Active |
| Milestone Spinal System | 9300031 | FDA UDI | Class II | Active |
| Fixed-Angle Reduction Screw | 8248060 | FDA UDI | Class II | Active |
| Iliac Screws | 803539070 | FDA UDI | Class II | Active |
| Fixed-Angle Reduction Screw | 8248030 | FDA UDI | Class II | Active |
| Planar Screw | 8264535 | FDA UDI | Class II | Active |
| Planar Reduction Screw | 803606040 | FDA UDI | Class II | Active |
| Milestone Spinal System | 9300015 | FDA UDI | Class II | Active |
| Iliac Screws | 803538565 | FDA UDI | Class II | Active |
| Iliac Screws | 803539085 | FDA UDI | Class II | Active |
| Closed Lateral Connector | 803845560 | FDA UDI | Class II | Active |
| Hook 5.5 | 8460005 | FDA UDI | Class II | Active |
| Iliac Screws | 803531080 | FDA UDI | Class II | Unknown |
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