510(k) K162567 ยท OLO Orthopedic Stereotaxic Instrument
ExactechGPS Total Shoulder Application, Equinoxe Planning Software
| Applicant | Blue Ortho, La Tronche, FR |
| Decision | Substantially Equivalent, Apr 5, 2017 |
| Received | Sep 14, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162567
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 18, 2018 | Exactech, Inc. Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool Terminated |
OLO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.