510(k) K180130 · KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
ELEOS Bipolar Acetabular System
| Applicant | Onkos Surgical, Inc., Parsippany NJ, US |
| Decision | Substantially Equivalent, Feb 23, 2018 |
| Received | Jan 17, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180130
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.