Kyphoplasty systems

Dilator w/Cannula

by Shanghai Kinetic Medical Co., Ltd.

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple bacteria associated with periodontal disease, and for determining the genetic risk for developing periodontal disease based on detection of gene fragments coding for interleukin-1-alpha and interleukin-1-beta, and the DRB1*04 gene coding for HLA-DR4 in a clinical specimen, using a nucleic acid technique (NAT). Organisms detected may include (but are not limited to) Porphyromonas, Prevotella, Tannerella, Actinobacillus and/or Treponema species.

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Where to buy Dilator w/Cannula

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Dilator w/Cannula models and sizes

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

Model / catalog no.SizeMRIStatus
FG2410Outer Diameter 4.2 mm Not statedAvailable

FDA clearances

  • 510(k) K113742 September 2012

Procedures that use kyphoplasty systems

Frequently asked questions

What is Dilator w/Cannula used for?

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple bacteria associated with periodontal disease, and for determining the genetic risk for developing periodontal disease based on detection of gene fragments coding for interleukin-1-alpha and interleukin-1-beta, and the DRB1*04 gene coding for HLA-DR4 in a clinical specimen, using a nucleic acid technique (NAT). Organisms detected may include (but are not limited to) Porphyromonas, Prevotella, Tannerella, Actinobacillus and/or Treponema species.

Who makes Dilator w/Cannula?

Dilator w/Cannula 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 w/Cannula come in?

Sizes listed for Dilator w/Cannula: Outer Diameter: 4.2 mm. Confirm availability with the manufacturer's instructions for use.

Is Dilator w/Cannula MRI safe?

The FDA device database entry for Dilator w/Cannula does not state its MRI safety status. Check the labeling before MRI.

Is Dilator w/Cannula FDA cleared?

Dilator w/Cannula 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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