510(k) K062898 ยท KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
SBI LATERAL RHEAD IMPLANT
| Applicant | Small Bone Innovations, Inc., New York NY, US |
| Decision | Substantially Equivalent, Nov 13, 2006 |
| Received | Sep 27, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062898
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 24, 2017 | Howmedica Osteonics Corp. Lateral Assembly, Radial Implant, Size 1 Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated |
KWI | None listed |
| Oct 24, 2017 | Howmedica Osteonics Corp. Lateral Assembly, Radial Stem Implant, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated |
KWI | None listed |
| Oct 24, 2017 | Howmedica Osteonics Corp. Lateral Assembly, Radial Stem Implant, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated |
KWI | None listed |
| Oct 24, 2017 | Howmedica Osteonics Corp. Lateral Assembly, Radial Stem Implant, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated |
KWI | None listed |
| Oct 24, 2017 | Howmedica Osteonics Corp. Lat Assembly, Rad Stem Implant,Collar 6mm, Size1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated |
KWI | None listed |
| Oct 24, 2017 | Howmedica Osteonics Corp. Lat Assembly, Rad Stem Implant,Collar 6mm,Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated |
KWI | None listed |
| Oct 24, 2017 | Howmedica Osteonics Corp. Lat Assembly, Rad Stem Implant,Collar 6mm,Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated |
KWI | None listed |
| Oct 24, 2017 | Howmedica Osteonics Corp. Lat Assembly, Rad Stem Implant,Collar 6mm,Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated |
KWI | None listed |
| Oct 24, 2017 | Howmedica Osteonics Corp. Lateral Assembly, Radial Head Implant, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated |
KWI | None listed |
| Oct 24, 2017 | Howmedica Osteonics Corp. Lateral Assembly, Radial Head Implant, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated |
KWI | None listed |
| Oct 24, 2017 | Howmedica Osteonics Corp. Lateral Assembly, Radial Head Implant, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated |
KWI | None listed |
| Oct 24, 2017 | Howmedica Osteonics Corp. Lateral Assembly, Radial Head Impl Assembly, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated |
KWI | None listed |
| Oct 24, 2017 | Howmedica Osteonics Corp. Lateral Assembly, Radial Head Impl Assembly, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated |
KWI | 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.