510(k) K003429 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
MALLOY/HEAD LATERALIZED PRESS-FIT FEMORAL
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Nov 30, 2000 |
| Received | Nov 3, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K003429
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.