510(k) K070963 ยท HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
REUNION HA FRACTURE STEM
| Applicant | Howmedica Osteonics Corp., Mahwah NJ, US |
| Decision | Substantially Equivalent, May 4, 2007 |
| Received | Apr 5, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K070963
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 26, 2009 | Stryker Howmedica Osteonics Corp. Reunion HA Fracture Stem
These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total Terminated |
HSD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.