510(k) K142187 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
LINK MP RECONSTRUCTION PROSTHESIS
| Applicant | Waldemar Link GmbH & Co. KG, Hamburg, DE |
| Decision | Substantially Equivalent, Nov 6, 2014 |
| Received | Aug 8, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142187
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 26, 2024 | Waldemar Link GmbH & Co. KG (Mfg Site) LINK MP Reconstruction System Neck Segment (with suture holes, standard, uncemented, L= 35 mm, CCD 126, Offset= 31 mm, Ti6Al4V, PoroLink, Taper 12/14.
Item Number: 99-0984/32
Intended for revision Open, Classified |
LZO | None listed |
| Dec 7, 2018 | Waldemar Link GmbH & Co. KG (Mfg Site) LINK STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTLESS (Size XS-0, D: 12mm, L: 160mm), Reference Number 172-916/12
Product Usage:
The LINK STEM with Microporous Surface MP Recons Terminated |
LZO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.