510(k) K190535 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
BiMobile Dual Mobility System - E-Dur Inserts
| Applicant | Waldemar Link GmbH & Co. KG, Norderstedt, DE |
| Decision | Substantially Equivalent, Aug 6, 2019 |
| Received | Mar 4, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190535
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 29, 2024 | Waldemar Link GmbH & Co. KG (Mfg Site) LINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head, 70mm Shell- Indicated for patients with mobility-limiting diseases, fractures or defects of the hip joint or proximal femur.
Item Number: Open, Classified |
LZO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.