Kyphoplasty systems
Choice Spine Lumbar Spacer System (SABRE, SHARK, HORNET, HARPOON)
A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.
Where to buy Choice Spine Lumbar Spacer System (SABRE, SHARK, HORNET, HARPOON)
We do not have contact details for Choice Spine, LP yet. Send a request and we will route it to the right person for your country.
Choice Spine Lumbar Spacer System (SABRE, SHARK, HORNET, HARPOON) 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 |
|---|---|---|---|
| P070-6023 | — | Not stated | Available |
| P070-6024 | — | Not stated | Available |
| SPCL-P059 | — | Not stated | Available |
| SPCL-P060 | — | Not stated | Available |
| SPCL-P061 | — | Not stated | Available |
| SPCL-P065 | — | Not stated | Available |
| SPCL-P066 | — | Not stated | Available |
| SPCL-P067 | — | Not stated | Available |
| SPCL-P068 | — | Not stated | Available |
FDA clearances
- 510(k) K073669 February 2008
Procedures that use kyphoplasty systems
Frequently asked questions
What is Choice Spine Lumbar Spacer System (SABRE, SHARK, HORNET, HARPOON) used for?
A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.
Who makes Choice Spine Lumbar Spacer System (SABRE, SHARK, HORNET, HARPOON)?
Choice Spine Lumbar Spacer System (SABRE, SHARK, HORNET, HARPOON) is made by Choice Spine, LP. It is listed under vertebral augmentation systems (kyphoplasty and vertebroplasty) in our device library.
What sizes does Choice Spine Lumbar Spacer System (SABRE, SHARK, HORNET, HARPOON) come in?
The FDA device database does not list sizes for Choice Spine Lumbar Spacer System (SABRE, SHARK, HORNET, HARPOON). Check the instructions for use or ask a Choice Spine, LP representative.
Is Choice Spine Lumbar Spacer System (SABRE, SHARK, HORNET, HARPOON) MRI safe?
The FDA device database entry for Choice Spine Lumbar Spacer System (SABRE, SHARK, HORNET, HARPOON) does not state its MRI safety status. Check the labeling before MRI.
Is Choice Spine Lumbar Spacer System (SABRE, SHARK, HORNET, HARPOON) FDA cleared?
Choice Spine Lumbar Spacer System (SABRE, SHARK, HORNET, HARPOON) is covered by FDA submission K073669.
How do I contact a Choice Spine, LP sales representative?
Choice Spine, LP has not listed representatives on LA Vascular yet. Visit the Choice Spine, LP 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.