510(k) K992525 ยท HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
ACUMED MODULAR SHOULDER SYSTEM
| Applicant | Acu Med, Inc., Beaverton OR, US |
| Decision | Substantially Equivalent, Feb 4, 2000 |
| Received | Jul 28, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992525
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 11, 2008 | Acumed LLC Modular Shoulder Body Assembly, Left (SH-1540L-S) and Modular Shoulder Body Assembly, Right (SH-1540R-S). Product labeled in part, "Acumed 5885 NW Cornelius Pass Road Hillsboro, OR 97124-9432 " Terminated |
HSD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.