510(k) K103384 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
ESCALADE ACETABULAR CUP SYSTEM
| Applicant | Ortho Development, Draper UT, US |
| Decision | Substantially Equivalent, Mar 16, 2011 |
| Received | Nov 18, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103384
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 13, 2012 | Ortho Development Corporation U-Joint Hex Head Driver 3.5mm, Part Number 228-0016, for the Escalade Acetabular Cup System. Driver is included in Part Number 270-9004-Escalade Acetabular Prep Kit and Part Number 228-9001-Triplus Ac Terminated |
LZO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.