510(k) K152764 ยท HAW Neurological Stereotaxic Instrument
EXACTECH GPS
| Applicant | Blue Ortho, La Tronche, FR |
| Decision | Substantially Equivalent, Jul 13, 2016 |
| Received | Sep 24, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152764
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 22, 2019 | Blue Ortho Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery in Knee Arthroplasty
Catalog Reference: L00002 Terminated |
OLO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.