510(k) K011819 ยท KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
RADIAL HEAD IMPLANT
| Applicant | Avanta Orthopaedics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jun 19, 2001 |
| Received | Jun 11, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K011819
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 29, 2013 | Small Bone Innovations, Inc. Small Bone Innovations (SBi) rHead Radial Stem, rHead Recon Radial System, rHead Radial Stem Lateral Assembly, rHead Radial Stem 6mm Collar, rHead Recon Radial Stem 6mm Collar, rHead Radial Stem Later Terminated |
KWI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.