510(k) K102180 ยท JDB Prosthesis, Elbow, Semi-Constrained, Cemented
RHEAD RADIAL HEAD EXTENDED STEMS
| Applicant | Small Bone Innovations, Inc., Morrisville PA, US |
| Decision | Substantially Equivalent, Dec 20, 2010 |
| Received | Aug 2, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102180
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 24, 2017 | Howmedica Osteonics Corp. rHead Standard Extended Stem, 6mm Collar, Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated |
JDB | None listed |
| Oct 24, 2017 | Howmedica Osteonics Corp. rHead Standard Extended Stem, 6mm Collar, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated |
JDB | None listed |
| Oct 24, 2017 | Howmedica Osteonics Corp. rHead Standard Extended Stem, 6mm Collar, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated |
JDB | None listed |
| Oct 24, 2017 | Howmedica Osteonics Corp. rHead Standard Extended Stem, 6mm Collar, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated |
JDB | None listed |
| Oct 24, 2017 | Howmedica Osteonics Corp. rHead Recon Extended Stem Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated |
JDB | None listed |
| Oct 24, 2017 | Howmedica Osteonics Corp. rHead Recon Extended Stem Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated |
JDB | None listed |
| Oct 24, 2017 | Howmedica Osteonics Corp. rHead Recon Extended Stem Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated |
JDB | None listed |
| Aug 20, 2015 | Stryker Howmedica Osteonics Corp. rHead Lateral Stem, Size 1, Do Not Reuse, Sterile. Intended for replacement of the proximal end of the radius. Terminated |
JDB | None listed |
| Aug 20, 2015 | Stryker Howmedica Osteonics Corp. Recon, Radial Implant, Standard Stem, Size 1, Sterile, Do Not Reuse, Rx Only. Intended for replacement of the proximal end of the radius. Terminated |
JDB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.