Spineology, Inc. · Class II · Cleared Dec 4, 2025
| K-number | K251943 |
| Device name | Spineology Navigation Instruments |
| Applicant | Spineology, Inc. |
| Product code | OLO |
| Device class | Class II |
| Decision date | Dec 4, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 882.4560 |
Spineology Navigation Instruments are reusable surgical instruments made of stainless steel used during spinal surgery to assist surgeons in precisely locating anatomical structures for placement of pedicle screws and an expandable interbody fusion portal. They are designed for use with the Medtronic StealthStation Spine System in open, minimally invasive, or percutaneous orthopedic procedures.
The OptiMesh Navigation Instruments for Portal Placement are identical to the predicate device in primary design features, materials of construction, function, fundamental scientific technology, principle of operation, device design, risk profile, and compatibility with Spineology and Medtronic systems. The only difference is addition of compatibility with Medtronic NavLock Tracker arrays for the dilator instrument, which was previously compatible only with SureTrak II Universal Trackers.
Not stated in this summary. The document mentions design verification testing including mating, registration, and accuracy testing, but does not cite specific consensus standards such as ISO, IEC, or ASTM.
View the full FDA submission: accessdata.fda.gov