Kyphoplasty systems
SteriSpine VA
A collection of sterile surgical instruments, tools, and materials designed to prepare and apply bone cement during an orthopaedic surgical procedure (e.g., hip replacement, arthroplasty, or vertebroplasty). It typically includes items such as forceps, a mallet, cement delivery injectors, delivery tubes, and mixing devices; it may or may not include bone cement. This is a single-use device.
Where to buy SteriSpine VA
We do not have contact details for Imedicom Co., Ltd. yet. Send a request and we will route it to the right person for your country.
SteriSpine VA 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 |
|---|---|---|---|
| KITKYPHO10 | — | Not stated | Available |
| KITKYPHO10B | — | Not stated | Available |
| KITKYPHO15 | — | Not stated | Available |
| KITKYPHO15B | — | Not stated | Available |
| KITKYPHO20 | — | Not stated | Available |
| KITKYPHO20B | — | Not stated | Available |
| SPICD-BI1/ SPICD-BIC1 | — | Not stated | Available |
| SPICD-CA1/ SPICD-NDB1 | — | Not stated | Available |
| SPICD-CA1/ SPICD-NDD1 | — | Not stated | Available |
| SPICD-CA1/ SPICD-NDT1 | — | Not stated | Available |
| SPICD-CA2/ SPICD-NDB2 | — | Not stated | Available |
| SPICD-CA2/ SPICD-NDD2 | — | Not stated | Available |
| SPICD-CA2/ SPICD-NDT2 | — | Not stated | Available |
| SPICD-CP1/ SPICD-CF1 | — | Not stated | Available |
| SPICD-CP1/ SPICD-CFS1 | — | Not stated | Available |
| SPICD-SP1 | — | Not stated | Available |
FDA clearances
- 510(k) K182287 April 2019
Procedures that use kyphoplasty systems
Frequently asked questions
What is SteriSpine VA used for?
A collection of sterile surgical instruments, tools, and materials designed to prepare and apply bone cement during an orthopaedic surgical procedure (e.g., hip replacement, arthroplasty, or vertebroplasty). It typically includes items such as forceps, a mallet, cement delivery injectors, delivery tubes, and mixing devices; it may or may not include bone cement. This is a single-use device.
Who makes SteriSpine VA?
SteriSpine VA is made by Imedicom Co., Ltd.. It is listed under vertebral augmentation systems (kyphoplasty and vertebroplasty) in our device library.
What sizes does SteriSpine VA come in?
The FDA device database does not list sizes for SteriSpine VA. Check the instructions for use or ask a Imedicom Co., Ltd. representative.
Is SteriSpine VA MRI safe?
The FDA device database entry for SteriSpine VA does not state its MRI safety status. Check the labeling before MRI.
Is SteriSpine VA FDA cleared?
SteriSpine VA is covered by FDA submission K182287.
How do I contact a Imedicom Co., Ltd. sales representative?
Imedicom Co., Ltd. has not listed representatives on LA Vascular yet. Visit the Imedicom Co., Ltd. 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.