Kyphoplasty systems
OsteoPearl Vertebral Balloon (15mm) & Inflation Device Kit, 10G
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 OsteoPearl Vertebral Balloon (15mm) & Inflation Device Kit, 10G
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OsteoPearl Vertebral Balloon (15mm) & Inflation Device Kit, 10G 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 |
|---|---|---|---|
| 100.410 | — | Not stated | Available |
FDA clearances
- 510(k) K200763 August 2020
Procedures that use kyphoplasty systems
Frequently asked questions
What is OsteoPearl Vertebral Balloon (15mm) & Inflation Device Kit, 10G 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 OsteoPearl Vertebral Balloon (15mm) & Inflation Device Kit, 10G?
OsteoPearl Vertebral Balloon (15mm) & Inflation Device Kit, 10G is made by Izi Medical Products, LLC. It is listed under vertebral augmentation systems (kyphoplasty and vertebroplasty) in our device library.
What sizes does OsteoPearl Vertebral Balloon (15mm) & Inflation Device Kit, 10G come in?
The FDA device database does not list sizes for OsteoPearl Vertebral Balloon (15mm) & Inflation Device Kit, 10G. Check the instructions for use or ask a Izi Medical Products, LLC representative.
Is OsteoPearl Vertebral Balloon (15mm) & Inflation Device Kit, 10G MRI safe?
The FDA device database entry for OsteoPearl Vertebral Balloon (15mm) & Inflation Device Kit, 10G does not state its MRI safety status. Check the labeling before MRI.
Is OsteoPearl Vertebral Balloon (15mm) & Inflation Device Kit, 10G FDA cleared?
OsteoPearl Vertebral Balloon (15mm) & Inflation Device Kit, 10G is covered by FDA submission K200763.
How do I contact a Izi Medical Products, LLC sales representative?
Izi Medical Products, LLC has not listed representatives on LA Vascular yet. Visit the Izi Medical Products, LLC 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.