510(k) K062775 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
EUROPEAN STYLE TAPER,PRESS-FIT HIP STEM
| Applicant | Ortho Development Corp., Draper UT, US |
| Decision | Substantially Equivalent, Jan 16, 2007 |
| Received | Sep 18, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062775
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 16, 2011 | Ortho Development Corporation Ovation Hip Stem, REF 201-0002, Hip Stem Inserter, Non-Sterile, Ortho Development, Draper, Utah 84020.
The Ovation Hip System is intended for use in total hip arthroplasty. The hip stem inserter is an Terminated |
LZO | None listed |
| Mar 16, 2011 | Ortho Development Corporation Ovation Hip Stem, REF 201-0102, Offset Stem Inserter RT, Non-Sterile, Ortho Development, Draper, Utah 84020.
The Ovation Hip System is intended for use in total hip arthroplasty. The hip stem inserter Terminated |
LZO | None listed |
| Mar 16, 2011 | Ortho Development Corporation Ovation Hip Stem, REF 201-0103, Offset Stem Inserter LT, Non-Sterile, Ortho Development, Draper, Utah 84020.
The Ovation Hip System is intended for use in total hip arthroplasty. The hip stem inserter Terminated |
LZO | None listed |
| Mar 16, 2011 | Ortho Development Corporation Ovation Hip Stem, REF 201-0104, Offset Stem Inserter Neutral, Non-Sterile, Ortho Development, Draper, Utah 84020.
The Ovation Hip System is intended for use in total hip arthroplasty. The hip stem ins Terminated |
LZO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.