510(k) K250182 ยท OLO Orthopedic Stereotaxic Instrument
Innovasis Navigation Instruments
| Applicant | Innovasis, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Mar 24, 2025 |
| Received | Jan 22, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250182
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 3, 2026 | Innovasis, Inc Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System Open, Classified |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.