510(k) K250086 ยท OLO Orthopedic Stereotaxic Instrument
OTS Hip
| Applicant | Ortoma AB, Gothenburg, SE |
| Decision | Substantially Equivalent, May 16, 2025 |
| Received | Jan 13, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250086
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 22, 2025 | ORTOMA AB Ortoma Inserter Adapter OTD:
Inserter Adapter OTD Straight REF 30-201
Model Number: 2001
UDI-DI code: 07350137521019
Inserter Adapter OTD Pinnacle Straight REF 30-202
Model Number: 1001
UDI-DI code: Open, Classified |
OLO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.