Kyphoplasty systems
KyphPak First Fracture Tray
by Medtronic Sofamor Danek, Inc.
A collection of sterile surgical instruments and devices used for the reduction of a vertebral compression fractures (VCFs) caused by trauma, cancer, or osteoporosis during a minimally invasive procedure commonly known as balloon kyphoplasty. It typically consists of a bone access needle, an osteo introducer, an inflation syringe, and the inflatable bone tamp. This procedure involves the insertion of the balloon tamp into a patient's back to reduce a vertebral body fracture by compression of cancellous bone and/or movement of the endplates as the balloon is inflated, and filling the void created with orthopaedic cement/filler to stabilize the vertebra. This is a single-use device.
Where to buy KyphPak First Fracture 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.
KyphPak First Fracture 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 |
|---|---|---|---|
| KEX102EB-CDS- | — | Not stated | Available |
| KEX152EB-CDS- | — | Not stated | Available |
| KEX202EB-CDS- | — | Not stated | Available |
| KPX103AB-CDS | — | Not stated | Available |
| KPX103PB-CDS | — | Not stated | Available |
| KPX103RB-CDS | — | Not stated | Available |
| KPX153AB-CDS | — | Not stated | Available |
| KPX153PB-CDS | — | Not stated | Available |
| KPX153RB-CDS | — | Not stated | Available |
| KPX203AB-CDS | — | Not stated | Available |
| KPX203PB-CDS | — | Not stated | Available |
| KPX203RB-CDS | — | Not stated | Available |
FDA clearances
- 510(k) K103231 January 2011
Procedures that use kyphoplasty systems
Frequently asked questions
What is KyphPak First Fracture Tray used for?
A collection of sterile surgical instruments and devices used for the reduction of a vertebral compression fractures (VCFs) caused by trauma, cancer, or osteoporosis during a minimally invasive procedure commonly known as balloon kyphoplasty. It typically consists of a bone access needle, an osteo introducer, an inflation syringe, and the inflatable bone tamp. This procedure involves the insertion of the balloon tamp into a patient's back to reduce a vertebral body fracture by compression of cancellous bone and/or movement of the endplates as the balloon is inflated, and filling the void created with orthopaedic cement/filler to stabilize the vertebra. This is a single-use device.
Who makes KyphPak First Fracture Tray?
KyphPak First Fracture 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 KyphPak First Fracture Tray come in?
The FDA device database does not list sizes for KyphPak First Fracture Tray. Check the instructions for use or ask a Medtronic Sofamor Danek, Inc. representative.
Is KyphPak First Fracture Tray MRI safe?
The FDA device database entry for KyphPak First Fracture Tray does not state its MRI safety status. Check the labeling before MRI.
Is KyphPak First Fracture Tray FDA cleared?
KyphPak First Fracture Tray is covered by FDA submission K103231.
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.