510(k) K002644 ยท KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
RADIAL HEAD IMPLANT
| Applicant | Avanta Orthopaedics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Nov 20, 2000 |
| Received | Aug 24, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002644
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 24, 2017 | Howmedica Osteonics Corp. rHead Stem Implant Plasma 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. rHead 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 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 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 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 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 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 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. rHead Recon Stem Implant Plasma 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. radial head implant #2 (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. radial head implant #3 (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. radial head implant #4 (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. radial stem implant #1 (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, Radial Implant 6 mm 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. radial stem implant #2 (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. radial stem implant #2 (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. radial stem implant #3 (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, Radial Implant 6 mm 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. radial stem implant #4 (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, Radial Implant 6 mm 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 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.