Kyphoplasty systems
KMC Balloon Catheter, 8 Gauge, 15mm
by Shanghai Kinetic Medical Co., Ltd.
A catheter-like device with an inflatable balloon at the distal end used for the reduction of fractures and/or creation of a void in cancellous bone [e.g., in the spine for a vertebral compression fracture (VCF), hand, tibia, radius, and calcaneus]. It is commonly used for kyphoplasty, which involves its insertion into a patient's back to reduce a vertebral body fracture by compression of cancellous bone and/or movement of the endplates as the balloon is inflated. After the device is removed, orthopaedic bone cement is introduced into the created void to stabilize the vertebra. This is a single-use device.
Where to buy KMC Balloon Catheter, 8 Gauge, 15mm
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.
KMC Balloon Catheter, 8 Gauge, 15mm 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 |
|---|---|---|---|
| KMC-003-10 | Balloon Length 10 mm | Not stated | Available |
| KMC-003-15 | Balloon Length 15 mm | Not stated | Available |
| KMC-003-20 | Balloon Diameter 20 mm | Not stated | Available |
FDA clearances
- 510(k) K113742 September 2012
Procedures that use kyphoplasty systems
Frequently asked questions
What is KMC Balloon Catheter, 8 Gauge, 15mm used for?
A catheter-like device with an inflatable balloon at the distal end used for the reduction of fractures and/or creation of a void in cancellous bone [e.g., in the spine for a vertebral compression fracture (VCF), hand, tibia, radius, and calcaneus]. It is commonly used for kyphoplasty, which involves its insertion into a patient's back to reduce a vertebral body fracture by compression of cancellous bone and/or movement of the endplates as the balloon is inflated. After the device is removed, orthopaedic bone cement is introduced into the created void to stabilize the vertebra. This is a single-use device.
Who makes KMC Balloon Catheter, 8 Gauge, 15mm?
KMC Balloon Catheter, 8 Gauge, 15mm 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 KMC Balloon Catheter, 8 Gauge, 15mm come in?
Sizes listed for KMC Balloon Catheter, 8 Gauge, 15mm: Balloon Length: 10–15 mm; Balloon Diameter: 20 mm. Confirm availability with the manufacturer's instructions for use.
Is KMC Balloon Catheter, 8 Gauge, 15mm MRI safe?
The FDA device database entry for KMC Balloon Catheter, 8 Gauge, 15mm does not state its MRI safety status. Check the labeling before MRI.
Is KMC Balloon Catheter, 8 Gauge, 15mm FDA cleared?
KMC Balloon Catheter, 8 Gauge, 15mm 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.