510(k) K200607 · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters
| Applicant | Waldemar Link GmbH & Co. KG, Norderstedt, DE |
| Decision | Substantially Equivalent, May 28, 2021 |
| Received | Mar 9, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200607
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 26, 2023 | Waldemar Link GmbH & Co. KG (Mfg Site) MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Insert Size F, +12mm Offset 20 degrees Inclination Open, Classified |
LPH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.