Kyphoplasty systems
Dilator
by Shanghai Kinetic Medical Co., Ltd.
A sterile, sharp, hollow tubular metal instrument designed for percutaneous insertion to provide access to any bone of the body for a bone biopsy needle or guidewire, or for a bone marrow aspiration technique, or for inserting therapeutic materials, including bone cements. It is typically inserted using a stylet under imaging [e.g., fluoroscopic, ultrasonic, computed tomography (CT)] control and has a proximal plastic handgrip to apply manual pressure and twist. This is a single-use device.
Where to buy Dilator
We do not have contact details for Shanghai Kinetic Medical Co., Ltd. yet. Send a request and we will route it to the right person for your country.
Dilator models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| FG2400 | — | Not stated | Available |
FDA clearances
- 510(k) K113742 September 2012
Procedures that use kyphoplasty systems
Frequently asked questions
What is Dilator used for?
A sterile, sharp, hollow tubular metal instrument designed for percutaneous insertion to provide access to any bone of the body for a bone biopsy needle or guidewire, or for a bone marrow aspiration technique, or for inserting therapeutic materials, including bone cements. It is typically inserted using a stylet under imaging [e.g., fluoroscopic, ultrasonic, computed tomography (CT)] control and has a proximal plastic handgrip to apply manual pressure and twist. This is a single-use device.
Who makes Dilator?
Dilator is made by Shanghai Kinetic Medical Co., Ltd.. It is listed under vertebral augmentation systems (kyphoplasty and vertebroplasty) in our device library.
What sizes does Dilator come in?
The FDA device database does not list sizes for Dilator. Check the instructions for use or ask a Shanghai Kinetic Medical Co., Ltd. representative.
Is Dilator MRI safe?
The FDA device database entry for Dilator does not state its MRI safety status. Check the labeling before MRI.
Is Dilator FDA cleared?
Dilator is covered by FDA submission K113742.
How do I contact a Shanghai Kinetic Medical Co., Ltd. sales representative?
Shanghai Kinetic Medical Co., Ltd. has not listed representatives on LA Vascular yet. Visit the Shanghai Kinetic Medical Co., Ltd. company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.