IN-DATE
315-0006: Spineology Verify Device
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| Price: | $213.00 per box of 1 |
|---|---|
| Quantity: | |
| In Stock: | 1 box of 1 |
| Expiration: | 11-2027 |
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AccessGUDID Info
- FDA Product Code: GBA
- FDA Product Code Name: Catheter, Balloon Type
- GMDN Term Code: 17541
- GMDN Term Name: Catheter/overtube balloon inflator, single-use
- GMDN Term Description: A device designed to inflate and regulate the pressure of the balloon of a catheter, endoscopic overtube, or other invasive device (e.g., tamp, endomicroscopy probe), typically by injecting and aspirating fluid or air within the balloon, and to deflate the balloon during a medical procedure. It typically consists of a dedicated manual syringe/plunger or electronic mechanism for inflation/deflation, an analogue or digital gauge/screen for monitoring pressure, a locking mechanism, and a connecting tube. This is a single-use device.
Manufacturer
Spineology is a spine medical device manufacturer specializing in minimally invasive lumbar fusion technology built around the OptiMesh expandable interbody platform. Spineology’s OptiMesh system is designed to be a conforming, patient-specific implant that is delivered through a small portal and then expanded and filled with bone graft in situ, supporting a broad range of lumbar interbody fusion approaches including open, MIS TLIF/PLIF, ultra minimally invasive OptiLIF, and endoscopic fusion with OptiLIF Endo. Spineology positions OptiMesh as a fusion scaffold optimized for efficient biologics delivery and footprint coverage while aiming to support clinical outcomes through published and IDE-level clinical validation, including the SCOUT IDE study.
