Kyphoplasty systems
KMC OneShot Single Balloon Assembly, 8 Gauge, 10mm
by Shanghai Kinetic Medical Co., Ltd.
A collection of sterile surgical instruments and devices used for the reduction of a vertebral compression fractures (VCFs) caused by trauma, cancer, or osteoporosis during a minimally invasive procedure commonly known as balloon kyphoplasty. It typically consists of a bone access needle, an osteo introducer, an inflation syringe, and the inflatable bone tamp. This procedure involves the insertion of the balloon tamp 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, and filling the void created with orthopaedic cement/filler to stabilize the vertebra. This is a single-use device.
Where to buy KMC OneShot Single Balloon Assembly, 8 Gauge, 10mm
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 OneShot Single Balloon Assembly, 8 Gauge, 10mm 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 |
|---|---|---|---|
| KMCA-201-10 | Balloon Length 10 mm; Needle Gauge 8 G | Not stated | Available |
| KMCA-201-15 | Balloon Length 15 mm; Needle Gauge 8 G | Not stated | Available |
| KMCA-201-20 | Balloon Length 20 mm; Needle Gauge 8 G | Not stated | Available |
FDA clearances
- 510(k) K113742 September 2012
Procedures that use kyphoplasty systems
Frequently asked questions
What is KMC OneShot Single Balloon Assembly, 8 Gauge, 10mm used for?
A collection of sterile surgical instruments and devices used for the reduction of a vertebral compression fractures (VCFs) caused by trauma, cancer, or osteoporosis during a minimally invasive procedure commonly known as balloon kyphoplasty. It typically consists of a bone access needle, an osteo introducer, an inflation syringe, and the inflatable bone tamp. This procedure involves the insertion of the balloon tamp 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, and filling the void created with orthopaedic cement/filler to stabilize the vertebra. This is a single-use device.
Who makes KMC OneShot Single Balloon Assembly, 8 Gauge, 10mm?
KMC OneShot Single Balloon Assembly, 8 Gauge, 10mm 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 OneShot Single Balloon Assembly, 8 Gauge, 10mm come in?
Sizes listed for KMC OneShot Single Balloon Assembly, 8 Gauge, 10mm: Balloon Length: 10–20 mm; Needle Gauge: 8 G. Confirm availability with the manufacturer's instructions for use.
Is KMC OneShot Single Balloon Assembly, 8 Gauge, 10mm MRI safe?
The FDA device database entry for KMC OneShot Single Balloon Assembly, 8 Gauge, 10mm does not state its MRI safety status. Check the labeling before MRI.
Is KMC OneShot Single Balloon Assembly, 8 Gauge, 10mm FDA cleared?
KMC OneShot Single Balloon Assembly, 8 Gauge, 10mm 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.