Kyphoplasty systems
KyphoPak Tray
by Medtronic Sofamor Danek, Inc.
A container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.
Where to buy KyphoPak Tray
We do not have contact details for Medtronic Sofamor Danek, Inc. yet. Send a request and we will route it to the right person for your country.
KyphoPak Tray 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 |
|---|---|---|---|
| KPX103AB | — | Not stated | Available |
| KPX103PB | — | Not stated | Available |
| KPX103RB | — | Not stated | Available |
| KPX153AB | — | Not stated | Available |
| KPX153PB | — | Not stated | Available |
| KPX153PB | — | Not stated | Available |
| KPX153RB | — | Not stated | Available |
| KPX203AB | — | Not stated | Available |
| KPX203PB | — | Not stated | Available |
| KPX203PB | — | Not stated | Available |
| KPX203RB | — | Not stated | Available |
FDA clearances
- 510(k) K101864 October 2010
Procedures that use kyphoplasty systems
Frequently asked questions
What is KyphoPak Tray used for?
A container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.
Who makes KyphoPak Tray?
KyphoPak Tray is made by Medtronic Sofamor Danek, Inc.. It is listed under vertebral augmentation systems (kyphoplasty and vertebroplasty) in our device library.
What sizes does KyphoPak Tray come in?
The FDA device database does not list sizes for KyphoPak Tray. Check the instructions for use or ask a Medtronic Sofamor Danek, Inc. representative.
Is KyphoPak Tray MRI safe?
The FDA device database entry for KyphoPak Tray does not state its MRI safety status. Check the labeling before MRI.
Is KyphoPak Tray FDA cleared?
KyphoPak Tray is covered by FDA submission K101864.
How do I contact a Medtronic Sofamor Danek, Inc. sales representative?
Medtronic Sofamor Danek, Inc. has not listed representatives on LA Vascular yet. Visit the Medtronic Sofamor Danek, 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.