510(k) K023604 ยท KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
MODIFICATION TO RADIAL HEAD IMPLANT
| Applicant | Avanta Orthopaedics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Nov 27, 2002 |
| Received | Oct 28, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K023604
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 24, 2017 | Howmedica Osteonics Corp. rHead Recon Stem Implant Plasma Coated, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated |
LTF | None listed |
| Oct 24, 2017 | Howmedica Osteonics Corp. rHead Recon Stem Implant Plasma Coated, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated |
LTF | None listed |
| Oct 24, 2017 | Howmedica Osteonics Corp. rHead Recon Stem Implant Plasma Coated, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated |
LTF | None listed |
| Oct 24, 2017 | Howmedica Osteonics Corp. rHead Recon Stem Implant 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 |
LTF | None listed |
| Oct 24, 2017 | Howmedica Osteonics Corp. rHead Recon Stem Implant 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 |
LTF | None listed |
| Oct 24, 2017 | Howmedica Osteonics Corp. rHead Recon Stem Implant 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 |
LTF | None listed |
| Oct 24, 2017 | Howmedica Osteonics Corp. rHead Recon Stem Implant 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 |
LTF | None listed |
| Oct 24, 2017 | Howmedica Osteonics Corp. #2 Bipolar radial head Implant (Sterile packed). 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. #3 Bipolar radial head Implant (Sterile packed). 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. #4 Bipolar radial head Implant (Sterile packed). 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. #1 Bipolar stem implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated |
LTF | None listed |
| Oct 24, 2017 | Howmedica Osteonics Corp. rHead Recon Stem Implant non-coated, Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated |
LTF | None listed |
| Oct 24, 2017 | Howmedica Osteonics Corp. #2 Bipolar stem implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated |
LTF | None listed |
| Oct 24, 2017 | Howmedica Osteonics Corp. rHead Recon Stem Implant non-coated, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated |
LTF | None listed |
| Oct 24, 2017 | Howmedica Osteonics Corp. #3 Bipolar stem implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated |
LTF | None listed |
| Oct 24, 2017 | Howmedica Osteonics Corp. rHead Recon Stem Implant non-coated, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated |
LTF | None listed |
| Oct 24, 2017 | Howmedica Osteonics Corp. #4 Bipolar stem implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated |
LTF | None listed |
| Oct 24, 2017 | Howmedica Osteonics Corp. rHead Recon Stem Implant non-coated, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated |
LTF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.