Kyphoplasty systems
PediFlex
A hand-held manual surgical instrument designed for the surgical insertion and/or extraction of a non-tissue based (inorganic) orthopaedic implant (e.g., a bone nail, spiral blade, or bone fixation plate). It is an instrument in a one-piece or modular configuration with a region that will attach/fit/lock to part of the implant, and typically features either a mechanism to apply a striking force (e.g., on a pad/flange) a mechanism for twisting (screwing) (e.g., T-handle), or a plunger mechanism to deploy a guide to drive the implant into place. This is a reusable device.
Where to buy PediFlex
We do not have contact details for Orthopediatrics Corp. yet. Send a request and we will route it to the right person for your country.
PediFlex 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 |
|---|---|---|---|
| 01-1001-0003 | — | Not stated | Available |
| 01-1001-0004 | — | Not stated | Available |
Procedures that use kyphoplasty systems
Frequently asked questions
What is PediFlex used for?
A hand-held manual surgical instrument designed for the surgical insertion and/or extraction of a non-tissue based (inorganic) orthopaedic implant (e.g., a bone nail, spiral blade, or bone fixation plate). It is an instrument in a one-piece or modular configuration with a region that will attach/fit/lock to part of the implant, and typically features either a mechanism to apply a striking force (e.g., on a pad/flange) a mechanism for twisting (screwing) (e.g., T-handle), or a plunger mechanism to deploy a guide to drive the implant into place. This is a reusable device.
Who makes PediFlex?
PediFlex is made by Orthopediatrics Corp.. It is listed under vertebral augmentation systems (kyphoplasty and vertebroplasty) in our device library.
What sizes does PediFlex come in?
The FDA device database does not list sizes for PediFlex. Check the instructions for use or ask a Orthopediatrics Corp. representative.
Is PediFlex MRI safe?
The FDA device database entry for PediFlex does not state its MRI safety status. Check the labeling before MRI.
Is PediFlex FDA cleared?
PediFlex is registered in the FDA's Global Unique Device Identification Database (GUDID).
How do I contact a Orthopediatrics Corp. sales representative?
Orthopediatrics Corp. has not listed representatives on LA Vascular yet. Visit the Orthopediatrics Corp. 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.