510(k) K010786 ยท KXE Prosthesis, Wrist, Hemi-, Ulnar
ULNAR HEAD IMPLANT
| Applicant | Avanta Orthopaedics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Apr 11, 2001 |
| Received | Mar 15, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K010786
| 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.