510(k) K122773 ยท OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
CROSS-OVER ACETABULAR SHELL & LINER
| Applicant | Stelkast Company, Mcmurray PA, US |
| Decision | Substantially Equivalent, Oct 9, 2012 |
| Received | Sep 10, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K122773
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 7, 2013 | Stelkast Co Stelkast Cross-over Acetabular Shell and Liner Hip System, Part Numbers SC3458-52, SC3474-52, SC3459-52, and SC3460-52.
Intended for use in reconstruction of the articulating surface of the acetabula Terminated |
OQG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.