510(k) K030055 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
MALLORY/HEAD TOTAL HIP SYSTEM; HA MALLORY/HEAD TOTAL HIP SYSTEM; BI-METRIC FEMORAL COMPONENTS
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Aug 11, 2003 |
| Received | Jan 6, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030055
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 21, 2019 | Zimmer Biomet, Inc. Various Hip systems, Item Nos. 104207
104212
104215
11-162809
11-162810
11-162811
11-162812
11-162813
21-103202
21-103203
21-103204
21-103205
21-103206
21-103207
21-103208
21-103209
21-103210
21-10321 Terminated |
LPH | None listed |
| Jun 11, 2015 | Biomet, Inc. Mallory/Head Primary Hip System; Size 11, 160 mm, Lateralized Femoral Stem; Ti-6Al-4V; Porous Plasma Uncemented, & Mallory/Head Total Hip System Size 12, 165 mm, Bi- Metric Femoral Components. Hip j Terminated |
LPH | None listed |
| Feb 17, 2015 | Biomet, Inc. Mallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150, hip prosthesis component (Ringloc) Terminated |
LPH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.