Kyphoplasty systems
Spider
A device intended to be used to dilate a body lumen or access channel to facilitate the introduction of endoscopic instruments percutaneously (through the skin) or through a natural orifice (e.g., urethra). It may be a flexible or rigid rod/tube with a tapered distal tip. This is a single-use device.
Spider 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 |
|---|---|---|---|
| SPS10N120 | — | MR Unsafe | Available |
| SPS10N125 | — | MR Unsafe | Available |
| SPS25S420 | — | MR Unsafe | Available |
| SPS25S425 | — | MR Unsafe | Available |
FDA clearances
- 510(k) K072198 June 2008
Procedures that use kyphoplasty systems
Frequently asked questions
What is Spider used for?
A device intended to be used to dilate a body lumen or access channel to facilitate the introduction of endoscopic instruments percutaneously (through the skin) or through a natural orifice (e.g., urethra). It may be a flexible or rigid rod/tube with a tapered distal tip. This is a single-use device.
Who makes Spider?
Spider is made by Sintea Plustek Srl. It is listed under vertebral augmentation systems (kyphoplasty and vertebroplasty) in our device library.
What sizes does Spider come in?
The FDA device database does not list sizes for Spider. Check the instructions for use or ask a Sintea Plustek Srl representative.
Is Spider MRI safe?
The FDA device database lists Spider as MR Unsafe. Always follow the specific MRI conditions in the labeling.
Is Spider FDA cleared?
Spider is covered by FDA submission K072198.
How do I contact a Sintea Plustek Srl sales representative?
Sintea Plustek Srl has not listed representatives on LA Vascular yet. Visit the Sintea Plustek Srl 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.