Kyphoplasty systems
KYPHON Xpede Bone Cement and KYPHON Mixer Pack
by Medtronic Sofamor Danek, Inc.
A substance designed to be used in arthroplastic and/or osteosynthetic procedures for the fixation of polymer or metallic implants to the living bone. It may also be intended for use as a filler in the case of bone pathologies (e.g., to stabilize and reinforce vertebral body structures in vertebroplasty and kyphoplasty). It is typically made from methylmethacrylate, polymethylmethacrylate (PMMA), esters of methacrylic acid or copolymers containing polymethylmethacrylate and polystyrene. This device does not contain an antimicrobial agent. After application, this device cannot be reused.
Where to buy KYPHON Xpede Bone Cement and KYPHON Mixer Pack
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KYPHON Xpede Bone Cement and KYPHON Mixer Pack 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 |
|---|---|---|---|
| CX01B | — | Not stated | Available |
| CX01B | — | Not stated | Available |
FDA clearances
- 510(k) K151227 November 2015
- 510(k) K102397 February 2011
Procedures that use kyphoplasty systems
Frequently asked questions
What is KYPHON Xpede Bone Cement and KYPHON Mixer Pack used for?
A substance designed to be used in arthroplastic and/or osteosynthetic procedures for the fixation of polymer or metallic implants to the living bone. It may also be intended for use as a filler in the case of bone pathologies (e.g., to stabilize and reinforce vertebral body structures in vertebroplasty and kyphoplasty). It is typically made from methylmethacrylate, polymethylmethacrylate (PMMA), esters of methacrylic acid or copolymers containing polymethylmethacrylate and polystyrene. This device does not contain an antimicrobial agent. After application, this device cannot be reused.
Who makes KYPHON Xpede Bone Cement and KYPHON Mixer Pack?
KYPHON Xpede Bone Cement and KYPHON Mixer Pack is made by Medtronic Sofamor Danek, Inc.. It is listed under vertebral augmentation systems (kyphoplasty and vertebroplasty) in our device library.
What sizes does KYPHON Xpede Bone Cement and KYPHON Mixer Pack come in?
The FDA device database does not list sizes for KYPHON Xpede Bone Cement and KYPHON Mixer Pack. Check the instructions for use or ask a Medtronic Sofamor Danek, Inc. representative.
Is KYPHON Xpede Bone Cement and KYPHON Mixer Pack MRI safe?
The FDA device database entry for KYPHON Xpede Bone Cement and KYPHON Mixer Pack does not state its MRI safety status. Check the labeling before MRI.
Is KYPHON Xpede Bone Cement and KYPHON Mixer Pack FDA cleared?
KYPHON Xpede Bone Cement and KYPHON Mixer Pack is covered by FDA submissions K102397, K151227.
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.