510(k) K062861 ยท HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
ASCENSION HUMERAL RESURFACING ARTHROPLASTY SYSTEM
| Applicant | Ascension Orthopedics, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Oct 31, 2006 |
| Received | Sep 25, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062861
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 16, 2018 | Ascension Orthopedics, Inc Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WW Terminated |
HSD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.