Changmei Medtech
Orthopedic (3)
This directory is the Department of orthopedics related medical instrument.
Kyphoplasty System Products (CE MDR Certificate and FDA Approval)
Components of Kyphoplasty System Products:
- Kyphoplasty Balloon Catheter: The device is mainly used in PKP operation to dilate vertebral body and form a cavity, which is for injecting bone cement to recover and stabilize vertebral body.
- Kyphoplasty Tool Kit: The device is mainly used for bone percutaneous intervention and establishing working channel by medical institutions.
- Balloon Inflator: The device is mainly used for hydraulic pressure on balloons to achieve the functure of balloon dilation.
Features:
- Minimally invasive surgery can reduce tissue injury and blood loss;
- The operation is simple, fast, and the operation time is greatly shortened;
- Local anesthesia can be adopted to reduce the risk of surgery and postoperative complications;
- The product can immediately relieve postoperative pain, effectively restore vertebral body height and correct spine kyphosis.
Kyphoplasty System Products List (8G)
| No. | Name | Model | Qty. |
| 1 | Kyphoplasty Balloon Catheter | KB0210/KB0115/KB0120 | 1 |
| 2 | Balloon Inflator | BI-20A-10 | 1 |
| 3 | Kyphoplasty Tool Kit | KT-00-01/KT-00-02/KT-00-03/KT-00-04 | 1 |
Kyphoplasty Tool Kit List (8G)
| No. | Name | Model | KT-00-01 | KT-00-02 | KT-00-03 | KT-00-04 |
| 1 | Puncture device | KT-01-01 | 2 | 2 | 1 | 1 |
| 2 | Puncture & Expandor device | KT-02-01 | 1 | / | 1 | / |
| 3 | Expandor device | KT-03-01 | 2 | 2 | 1 | 1 |
| 4 | Bone drill | KT-05-01 | 1 | 1 | 1 | 1 |
| 5 | Guide wire | KT-06-01 | 2 | 3 | 1 | 1 |
| 6 | Bone cement filling device | KT-04-01 | 6 | 6 | 3 | 3 |
Kyphoplasty System Products List (11G)
| No. | Name | Model | Qty. |
| 1 | Kyphoplasty Balloon Catheter | KB0210S/KB0115S/KB0120S | 1 |
| 2 | Balloon Inflator | BI-20A-10 | 1 |
| 3 | Kyphoplasty Tool Kit | KT-00-05/KT-00-06 | 1 |
Kyphoplasty Tool Kit List (11G)
| No. | Name | Model | KT-00-05 | KT-00-06 |
| 1 | Puncture & Expandor device | KT-07-01 | 2 | 1 |
| 2 | Bone cement filling device | KT-08-01 | 6 | 1 |
| 3 | Bone drill | KT-09-01 | 1 | 1 |
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Kyphoplasty Balloon Catheter (CE MDR Certificate and FDA Approval)
Intended use:
This device is mainly used in Percutaneous Kyphoplasty(PKP) operation to dilate vertebral body and form a cavum which is for injecting bone cement to recover and stabilize vertebral body.
Features:
- Kyphoplasty Balloon Catheter is designed for correcting compression fractures and restoring vertebral body height. Doctors should choose
appropriate balloon for dilation according to fracture types; - Different OD of the sheath can be applied to different working channel to realize accurate dilation. Different shapes of the balloon can adapt to different thoracic vertebra, lumbar vertebra as well as other types of fractures;
- The balloon materials feature with excellent characteristics, such as fine supportiveness, biocompatibility, biological persistence, surface anti-biodegradation and environmental stress cracking resistance;
- Standard four-wing pleating process ensures excellent passability after repeated inflation;
- Each balloon has passed the pressure and seal test before leaving the factory. Strict quality control measures minimize the risk of balloon burst and leakage.
Specifications:
| Model | Size | Chaneel I.D. | Overall Length | Maximum Volume | PSI Rating | Balloon Shape | |
| KB0210S |
11G |
10 |
≥3.1mm |
280mm |
3CC |
400PSI |
Cylindrical Type |
| KB0115S | 15 | 4CC | Peanut Type | ||||
| KB0120S | 20 | 5CC | Peanut Type | ||||
| KB0210 |
8G |
10 |
≥3.6mm |
315mm |
4CC | Cylindrical Type | |
| KB0115 | 15 | 4CC | Peanut Type | ||||
| KB0120 | 20 | 6CC | Peanut Type | ||||
Customization is also acceptable to our balloons.
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Balloon Inflator (CE MDR Certificate and FDA Approval)
Intended use:
This device is mainly used for hydraulic pressure on balloons to achieve the function of balloon dilation.
Features:
- Optimal head fluid channel design makes it convenient for venting;
- O-type plunger design makes for low frictional resistance and can pressure easily;
- Screw fixed design of pressure gauge assures safety and reliability of the seal;
- The inflator is equipped with fluorescent gauge, which contributes to accuracy of reading;
- Ergonomic handle is comfortable and convenient to grasp;
- The inflator is of good leakproofness since it uses materials with high strength and safety;
Specifications:
| Model | Nominal Capacity（ml） | Maximum Pressure（atm） | Syring Features |
| BI-20A-10 | 20 | 30 | 10ml |
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