510(k) K193618 ยท OLO Orthopedic Stereotaxic Instrument
ExactechGPS System
| Applicant | Blue Ortho, Gieres, FR |
| Decision | Substantially Equivalent, Sep 2, 2020 |
| Received | Dec 26, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193618
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 10, 2020 | Blue Ortho Instructions For Use document of the GPS Trackers. Terminated |
OLO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.