IN-DATE
530-0084: Spineology NiTi Guide Pin, 1.4 x 610 Blunt (Non-Sterile)
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| Price: | $18.50 per box of 2 |
|---|---|
| Quantity: | |
| In Stock: | 2 box of 2 |
| Status: | Non-sterile |
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AccessGUDID Info
- FDA Product Code: LXH
- FDA Product Code Name: Orthopedic Manual Surgical Instrument
- GMDN Term Code: 58927
- GMDN Term Name: Orthopaedic prosthesis implantation positioning instrument, single-use
- GMDN Term Description: A hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. 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.
