Kyphoplasty systems

KMC OneShot Working Channel, 10 Gauge, Pyramid Tip

by Shanghai Kinetic Medical Co., Ltd.

A collection of sterile manual devices intended to create a percutaneous access channel within a vertebral body or other bones (e.g., hand, radius, tibia, calcaneus) prior to the use of an inflatable balloon (e.g., a balloon catheter or balloon tamp) to create a bone space during kyphoplasty/osteoplasty. It typically consists of bone access needles/cannulae, orthopaedic bone wires (Kirschner wires), a drill, and a curette. It is used in orthopaedic surgery, typically under fluoroscopic guidance, to treat a patient diagnosed with compression fractures. This is a single-use device.

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Where to buy KMC OneShot Working Channel, 10 Gauge, Pyramid Tip

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KMC OneShot Working Channel, 10 Gauge, Pyramid Tip models and sizes

From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.

Model / catalog no.SizeMRIStatus
KMC-010-03Needle Gauge 10 G Not statedAvailable

FDA clearances

  • 510(k) K113742 September 2012

Procedures that use kyphoplasty systems

Frequently asked questions

What is KMC OneShot Working Channel, 10 Gauge, Pyramid Tip used for?

A collection of sterile manual devices intended to create a percutaneous access channel within a vertebral body or other bones (e.g., hand, radius, tibia, calcaneus) prior to the use of an inflatable balloon (e.g., a balloon catheter or balloon tamp) to create a bone space during kyphoplasty/osteoplasty. It typically consists of bone access needles/cannulae, orthopaedic bone wires (Kirschner wires), a drill, and a curette. It is used in orthopaedic surgery, typically under fluoroscopic guidance, to treat a patient diagnosed with compression fractures. This is a single-use device.

Who makes KMC OneShot Working Channel, 10 Gauge, Pyramid Tip?

KMC OneShot Working Channel, 10 Gauge, Pyramid Tip 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 Working Channel, 10 Gauge, Pyramid Tip come in?

Sizes listed for KMC OneShot Working Channel, 10 Gauge, Pyramid Tip: Needle Gauge: 10 G. Confirm availability with the manufacturer's instructions for use.

Is KMC OneShot Working Channel, 10 Gauge, Pyramid Tip MRI safe?

The FDA device database entry for KMC OneShot Working Channel, 10 Gauge, Pyramid Tip does not state its MRI safety status. Check the labeling before MRI.

Is KMC OneShot Working Channel, 10 Gauge, Pyramid Tip FDA cleared?

KMC OneShot Working Channel, 10 Gauge, Pyramid Tip 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.

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