510(k) K053293 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
ENCOMPASS 10*17 AND 12*17 EXTENDED PRESS-FIT HIP STEMS
| Applicant | Ortho Development Corp., Draper UT, US |
| Decision | Substantially Equivalent, Feb 16, 2006 |
| Received | Nov 25, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053293
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 20, 2011 | Ortho Development Corporation Encompass Hip Stem, Plasma Spray, 12/14 Taper, Standard, REF 108-XXXX, Sterile R, Ortho Development, Draper, Utah 84020.
Intended for use in total hip arthroscopy. Device fixation is achieved by an o Terminated |
MBL | None listed |
| Jun 20, 2011 | Ortho Development Corporation Encompass Hip Stem, Plasma Spray, 12/14 Taper, Extended, REF 109-XXXX, Sterile R, Ortho Development, Draper, Utah 84020.
Intended for use in total hip arthroscopy. Device fixation is achieved by an o Terminated |
MBL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.