510(k) K070236 ยท JDB Prosthesis, Elbow, Semi-Constrained, Cemented
SBI LATERAL RADIO CAPITELLUM
| Applicant | Small Bone Innovations, Inc., Newyork NY, US |
| Decision | Substantially Equivalent, Feb 21, 2007 |
| Received | Jan 25, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K070236
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 20, 2015 | Stryker Howmedica Osteonics Corp. Radio-Capitellum, Capitellum, Left, Large, Do Not Reuse, Rx Only. Indicated for use in the elbow for reduction or relief of pain and/or improved elbow function in skeletally mature patients. Terminated |
JDB | None listed |
| 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.