510(k) K130610 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
SIRIUS FEMORAL STEM
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Aug 30, 2013 |
| Received | Mar 7, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130610
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 17, 2014 | Biomet, Inc. Device Brand Name: Sirius Polish Cemented Stem 34B
Device Classification Name: prosthesis, hip, semi-constrained, metal/polymer, cemented
Device Common Name: Sirius Femoral Stem
The Biomet's Sirius F Terminated |
JDI | None listed |
| Dec 17, 2014 | Biomet, Inc. Sirius Polish Cemented Stem 38C
Catalog Number: 51-199335
Lot Number Identification: 141680, 180920
The Biomet's Sirius Femoral Hip Stem is a double-tapered, highly polished cemented hip stem, design Terminated |
JDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.