510(k) K213546 ยท OLO Orthopedic Stereotaxic Instrument
ExactechGPS Total Shoulder Application, Equinoxe Planning Software
| Applicant | Blue Ortho, Meylan, FR |
| Decision | Substantially Equivalent, Jan 6, 2022 |
| Received | Nov 8, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213546
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 30, 2023 | Exactech, Inc. Exactech Shoulder GPS Impactor Handle, Catalog #531-07-05. Open, Classified |
OLO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.