510(k) K133370 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
REMEDY HIP STEM, PEGASUS HIP STEM, EVOLVE HELIOS HIP STEM, EVOLVE MASTERS HIP STEM, EVOLVE DISTAL CENTRALIZER, EVOLVE CE
| Applicant | Signature Orthopaedics Pty Limited, Nsw, AU |
| Decision | Substantially Equivalent, Jul 22, 2014 |
| Received | Nov 4, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133370
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.