300-3032: Spineology Optimesh Expandable Interbody Fusion System, 8cc Fill Volume

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| Price: | $4,499.00 per box of 1 |
|---|---|
| Quantity: | |
| In Stock: | 1 box of 1 |
| Expiration: | 11-2027 |
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Additional Details
Spineology Optimesh Expandable Interbody Fusion System
The OptiMesh Multiplanar Expandable Interbody Fusion System mesh implant is a porous container knitted from polyester yarn made of polyethylene terephthalate (PET) thread and offered in three sizes. Each mesh is supplied on a disposable holder for ease of handling and placement. The OptiMesh device is packaged into double Tyvek/Mylar film pouches, placed in a carton, and then terminally sterilized by gamma radiation. The PET material is radiolucent and is not bioresorbable.
The OptiMesh device is designed to contain and allow compaction of bone graft material. The compaction process during filling deploys the mesh and provides containment to allow formation of a solid graft pack capable of supporting axial load with posterior supplemental fixation. The bone graft material placed within the mesh device includes AFT Allograft Filler Tube, which is provided in pre-filled delivery tubes.
AccessGUDID Info
- FDA Product Code: OQB
- FDA Product Code Name: Intervertebral Body Graft Containment Device
- GMDN Term Code: 60762
- GMDN Term Name: Polymeric spinal interbody fusion cage
- GMDN Term Description: 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.
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.
IN-DATE