Kyphoplasty systems
Affiniti
A hand-held manual surgical instrument designed to strike a surface or another device (e.g., a surgical chisel, gouge, driver) to drive it during a surgical intervention. It is available in a variety of designs and materials; the shaft is typically made of metal (e.g., chromed iron (Fe) or high-grade stainless steel), but can be made of synthetic materials (e.g., Tufnol), and tapers distally to the head. The head is typically a solid, cylindrical shape normally being double-ended and made of solid (iron/steel) or shock-absorbing materials (e.g., rubber, plastic, or Tufnol). Also referred to as a surgical hammer it may also be used for autopsy. This is a reusable device.
Where to buy Affiniti
We do not have contact details for Tornier, Inc. yet. Send a request and we will route it to the right person for your country.
Affiniti 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 |
|---|---|---|---|
| 9000323 | — | Not stated | Available |
Procedures that use kyphoplasty systems
Frequently asked questions
What is Affiniti used for?
A hand-held manual surgical instrument designed to strike a surface or another device (e.g., a surgical chisel, gouge, driver) to drive it during a surgical intervention. It is available in a variety of designs and materials; the shaft is typically made of metal (e.g., chromed iron (Fe) or high-grade stainless steel), but can be made of synthetic materials (e.g., Tufnol), and tapers distally to the head. The head is typically a solid, cylindrical shape normally being double-ended and made of solid (iron/steel) or shock-absorbing materials (e.g., rubber, plastic, or Tufnol). Also referred to as a surgical hammer it may also be used for autopsy. This is a reusable device.
Who makes Affiniti?
Affiniti is made by Tornier, Inc.. It is listed under vertebral augmentation systems (kyphoplasty and vertebroplasty) in our device library.
What sizes does Affiniti come in?
The FDA device database does not list sizes for Affiniti. Check the instructions for use or ask a Tornier, Inc. representative.
Is Affiniti MRI safe?
The FDA device database entry for Affiniti does not state its MRI safety status. Check the labeling before MRI.
Is Affiniti FDA cleared?
Affiniti is registered in the FDA's Global Unique Device Identification Database (GUDID).
How do I contact a Tornier, Inc. sales representative?
Tornier, Inc. has not listed representatives on LA Vascular yet. Visit the Tornier, Inc. 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.