510(k) K163577 · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Ecofit® Hip System
| Applicant | Implantcast GmbH, Buxtehude, DE |
| Decision | Substantially Equivalent, Sep 25, 2017 |
| Received | Dec 20, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163577
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 9, 2021 | IMPLANTCAST GMBH EcoFit cup cementless:
Model(Catalog Number)/Description:
02200046 /EcoFit cup cementless 46mm dia incl. central hole cover;
02200048 /EcoFit cup cementless 48mm dia incl. central hole cover;
02200 Terminated |
LZO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.