510(k) K131845 ยท KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS, ACUMED ARH SLIDE-LOC
| Applicant | Acumed, LLC, Hillsboro OR, US |
| Decision | Substantially Equivalent, Sep 30, 2013 |
| Received | Jun 21, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131845
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 20, 2017 | Acumed LLC The Acumed Slide-Loc Anatomic Radial Head System is intended for use by surgeons with orthopedic training. The device is to be implanted by the surgeon in a sterile operating room setting. Implants Terminated |
KWI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.