510(k) K061146 ยท KXE Prosthesis, Wrist, Hemi-, Ulnar
SBI ULNAR HEAD IMPLANT
| Applicant | Small Bone Innovations, Inc., New York NY, US |
| Decision | Substantially Equivalent, Jul 19, 2006 |
| Received | Apr 25, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K061146
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 20, 2015 | Stryker Howmedica Osteonics Corp. uHead, Ulnar Implant, Standard Stem, Size 1, Sterile, Rx Only. Intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty. Terminated |
KXE | None listed |
| Aug 20, 2015 | Stryker Howmedica Osteonics Corp. Sigmoid Notch, Radial Plate, Small, Sterile, Do Not Reuse, Rx Only. Intended for replacement of the distal radio-ulnar joint following ulnar head resection arthroplasty. Terminated |
KXE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.