510(k) K171273 · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
LINK® BiMobile(TM) Dual Mobility System
| Applicant | Waldemar Link GmbH & Co. KG, Hamburg, DE |
| Decision | Substantially Equivalent, Jan 19, 2018 |
| Received | May 1, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171273
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 4, 2018 | Waldemar Link GmbH & Co. KG (Mfg Site) BiMobile UHMWPE Liner: ID-28mm/OD-50mm, Reference Number 184-260/02
The LINK BiMobile Dual Mobility System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot Terminated |
MEH | None listed |
| Dec 4, 2018 | Waldemar Link GmbH & Co. KG (Mfg Site) BiMobile UHMWPE Liner: ID-28mm/OD-54mm, Reference Number 184-260/04
The LINK BiMobile Dual Mobility System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot Terminated |
MEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.