510(k) K201189 ยท OLO Orthopedic Stereotaxic Instrument
Stealthstation S8 Spine Software v1.3.0
| Applicant | Medtronic Navigation, Inc., Louisville CO, US |
| Decision | Substantially Equivalent, May 29, 2020 |
| Received | May 1, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K201189
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 10, 2024 | Medtronic Navigation, Inc. StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762)
The StealthStation System, with StealthStation Spine software, is intended as an aid for precisely locating anatomical structures in Open, Classified |
OLO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.