510(k) K111097 ยท HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
HUMELOCK CEMENTED SHOULDER PROSTHESIS
| Applicant | Fx Solutions, Viriat, FR |
| Decision | Substantially Equivalent, Nov 9, 2011 |
| Received | Apr 20, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111097
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 4, 2018 | Fx Solutions Fx SOLUTIONS CENTERED HEAD CoCr 50x19, REF 106-5019
Product Usage:
Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susce Terminated |
HSD | None listed |
| Jun 4, 2018 | Fx Solutions Fx SOLUTIONS OFFSET HEAD CoCr 50x20, REF 106-5000
Product Usage:
Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions suscept Terminated |
HSD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.