510(k) K141395 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
DELTA TT ACETABULAR SYSTEM
| Applicant | Lima Corporate S.P.A., Udine, IT |
| Decision | Substantially Equivalent, Jun 30, 2014 |
| Received | May 28, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K141395
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 8, 2017 | Limacorporate S.p.A Delta Cup Beater Positioner - Aligner, model # 9057.20.555
Used during implantation of the Delta Acetabular System Completed |
LXH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.