Kyphoplasty systems
Novel
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.
Novel 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 |
|---|---|---|---|
| 64091 | — | Not stated | Available |
| 64093 | — | Not stated | Available |
| 64097-01 | — | Not stated | Available |
| 64097-02 | — | Not stated | Available |
| 64630-01 | — | Not stated | Available |
| 64630-02 | — | Not stated | Available |
| 64630-03 | — | Not stated | Available |
| 64640-01 | — | Not stated | Available |
| 64640-02 | — | Not stated | Available |
| 64640-03 | — | Not stated | Available |
| 64640-04 | — | Not stated | Available |
| 64640-05 | — | Not stated | Available |
| 64640-06 | — | Not stated | Available |
| 64640-07 | — | Not stated | Available |
| 64650-01 | — | Not stated | Available |
| 64650-02 | — | Not stated | Available |
| 64823-01 | — | Not stated | Available |
| 64825-01 | — | Not stated | Available |
| 64827-01 | — | Not stated | Available |
| 64902-01 | — | Not stated | Available |
| 64902-02 | — | Not stated | Available |
| 64902-03 | — | Not stated | Available |
| 64902-04 | — | Not stated | Available |
| 64906-01 | — | Not stated | Available |
| 64906-02 | — | Not stated | Available |
| 64922-01 | — | Not stated | Available |
| 64922-02 | — | Not stated | Available |
| 64922-03 | — | Not stated | Available |
| CI-10093 | — | Not stated | Available |
Procedures that use kyphoplasty systems
Frequently asked questions
What is Novel 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 Novel?
Novel is made by Alphatec Spine, Inc.. It is listed under vertebral augmentation systems (kyphoplasty and vertebroplasty) in our device library.
What sizes does Novel come in?
The FDA device database does not list sizes for Novel. Check the instructions for use or ask a Alphatec Spine, Inc. representative.
Is Novel MRI safe?
The FDA device database entry for Novel does not state its MRI safety status. Check the labeling before MRI.
Is Novel FDA cleared?
Novel is registered in the FDA's Global Unique Device Identification Database (GUDID).
How do I contact a Alphatec Spine, Inc. sales representative?
Alphatec Spine, Inc. has not listed representatives on LA Vascular yet. Visit the Alphatec Spine, 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.