Kyphoplasty systems
Pisces-SA
A hand-held, surgical instrument designed to be used to manually pack tissue or other material during a surgical intervention. It typically consists of a shaft that terminates in a blunt (flat or profiled) tip at the distal end and a handle at the proximal end. It is typically a one-piece instrument made of metal, however some types may employ a synthetic material for the handle (e.g., Tufnol). The surgeon may pack the material by applying hand pressure to the device or by tapping the proximal end with a hammer/mallet. This is a reusable device.
Where to buy Pisces-SA
We do not have contact details for Osseus Fusion Systems, LLC yet. Send a request and we will route it to the right person for your country.
Pisces-SA 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 |
|---|---|---|---|
| 1750-0002 | — | Not stated | Available |
| 1750-0003 | — | Not stated | Available |
| 1750-0004 | — | Not stated | Available |
FDA clearances
- 510(k) K213935 May 2022
Procedures that use kyphoplasty systems
Frequently asked questions
What is Pisces-SA used for?
A hand-held, surgical instrument designed to be used to manually pack tissue or other material during a surgical intervention. It typically consists of a shaft that terminates in a blunt (flat or profiled) tip at the distal end and a handle at the proximal end. It is typically a one-piece instrument made of metal, however some types may employ a synthetic material for the handle (e.g., Tufnol). The surgeon may pack the material by applying hand pressure to the device or by tapping the proximal end with a hammer/mallet. This is a reusable device.
Who makes Pisces-SA?
Pisces-SA is made by Osseus Fusion Systems, LLC. It is listed under vertebral augmentation systems (kyphoplasty and vertebroplasty) in our device library.
What sizes does Pisces-SA come in?
The FDA device database does not list sizes for Pisces-SA. Check the instructions for use or ask a Osseus Fusion Systems, LLC representative.
Is Pisces-SA MRI safe?
The FDA device database entry for Pisces-SA does not state its MRI safety status. Check the labeling before MRI.
Is Pisces-SA FDA cleared?
Pisces-SA is covered by FDA submission K213935.
How do I contact a Osseus Fusion Systems, LLC sales representative?
Osseus Fusion Systems, LLC has not listed representatives on LA Vascular yet. Visit the Osseus Fusion Systems, LLC 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.