510(k) K051385 ยท KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Aug 5, 2005 |
| Received | May 27, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051385
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 16, 2017 | Zimmer Biomet, Inc. ExploR Radial Head Replacement System. PN: 11-210061 LN: 243610.
The stem is placed inside a polyurethane bag. The bagged component will then be placed in an inner PETG tray. The screw will be placed Terminated |
KWI | None listed |
| May 13, 2014 | Biomet, Inc. ExploR 7x26mm Modular Radial Stem, Catalog number 11-210062. Elbow prosthesis orthopedic implant. Terminated |
KWI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.