Kyphoplasty systems
Na
by Synthes GmbH
A hand-held manual surgical instrument designed to push a cartilage or bone graft into a position from which the graft can be delivered into a chondral defect [e.g., during anterior cruciate ligament (ACL) reconstruction surgery]. This device is available in a variety of designs, such as a plunger made of high-grade materials [e.g., stainless steel or titanium (Ti)] used to advance the graft down its tubular-shaped holder or possibly a bone graft funnel and into place; it is also available in a variety of sizes. This is a reusable device.
Where to buy Na
We do not have contact details for Synthes GmbH yet. Send a request and we will route it to the right person for your country.
Na 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 |
|---|---|---|---|
| 03.804.413S | — | Not stated | Available |
| 03.815.023 | — | Not stated | Available |
| 03.815.024 | — | Not stated | Available |
| 03.820.144 | — | Not stated | Available |
| 356.301 | — | Not stated | Available |
| 356.302 | — | Not stated | Available |
| 356.303 | — | Not stated | Available |
| 359.205 | — | Not stated | Available |
| 359.206 | — | Not stated | Available |
| 359.220 | — | Not stated | Available |
| SD03.632.215 | — | Not stated | Available |
| SD03.632.216 | — | Not stated | Available |
| SD03.632.217 | — | Not stated | Available |
| SD03.632.219 | — | Not stated | Available |
| SD03.632.230 | — | Not stated | Available |
| SD03.632.231 | — | Not stated | Available |
| SD03.632.232 | — | Not stated | Available |
| SD03.632.233 | — | Not stated | Available |
| SD03.632.370 | — | Not stated | Available |
| SD03.632.372 | — | Not stated | Available |
| SD03.632.374 | — | Not stated | Available |
| SD03.632.377 | — | Not stated | Available |
| SD329.011 | — | Not stated | Available |
| SD359.205 | — | Not stated | Available |
| SD359.206 | — | Not stated | Available |
| SD359.207 | — | Not stated | Available |
| SD359.208 | — | Not stated | Available |
| SD359.209 | — | Not stated | Available |
| SD359.210 | — | Not stated | Available |
| SD359.211 | — | Not stated | Available |
| SD359.212 | — | Not stated | Available |
| SD391.004 | — | Not stated | Available |
FDA clearances
- 510(k) K110604 December 2011
Procedures that use kyphoplasty systems
Frequently asked questions
What is Na used for?
A hand-held manual surgical instrument designed to push a cartilage or bone graft into a position from which the graft can be delivered into a chondral defect [e.g., during anterior cruciate ligament (ACL) reconstruction surgery]. This device is available in a variety of designs, such as a plunger made of high-grade materials [e.g., stainless steel or titanium (Ti)] used to advance the graft down its tubular-shaped holder or possibly a bone graft funnel and into place; it is also available in a variety of sizes. This is a reusable device.
Who makes Na?
Na is made by Synthes GmbH. It is listed under vertebral augmentation systems (kyphoplasty and vertebroplasty) in our device library.
What sizes does Na come in?
The FDA device database does not list sizes for Na. Check the instructions for use or ask a Synthes GmbH representative.
Is Na MRI safe?
The FDA device database entry for Na does not state its MRI safety status. Check the labeling before MRI.
Is Na FDA cleared?
Na is covered by FDA submission K110604.
How do I contact a Synthes GmbH sales representative?
Synthes GmbH has not listed representatives on LA Vascular yet. Visit the Synthes GmbH 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.