510(k) K912654 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
OMNIFIT EPF DUAL GEOMETRY ACETABULAR CUP
| Applicant | Osteonics Corp., Allendale NJ, US |
| Decision | Substantially Equivalent, Aug 16, 1991 |
| Received | Jun 17, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912654
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 7, 2011 | Stryker Howmedica Osteonics Corp. Omnifit M/S PSL Porous Coated Acetabular Shell 40MM;
Stryker Orthopaedics,
Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from Terminated |
MEH | None listed |
| Feb 7, 2011 | Stryker Howmedica Osteonics Corp. Omnifit M/S PSL Porous Coated Acetabular Shell 42MM;
Stryker Orthopaedics,
Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from Terminated |
MEH | None listed |
| Feb 7, 2011 | Stryker Howmedica Osteonics Corp. Omnifit M/S PSL Porous Coated Acetabular Shell 44MM;
Stryker Orthopaedics,
Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from Terminated |
MEH | None listed |
| Feb 7, 2011 | Stryker Howmedica Osteonics Corp. Omnifit M/S PSL Porous Coated Acetabular Shell 46MM;
Stryker Orthopaedics,
Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from Terminated |
MEH | None listed |
| Feb 7, 2011 | Stryker Howmedica Osteonics Corp. Omnifit M/S PSL Porous Coated Acetabular Shell 48MM;
Stryker Orthopaedics,
Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from Terminated |
MEH | None listed |
| Feb 7, 2011 | Stryker Howmedica Osteonics Corp. Omnifit M/S PSL Porous Coated Acetabular Shell 50MM;
Stryker Orthopaedics,
Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from Terminated |
MEH | None listed |
| Feb 7, 2011 | Stryker Howmedica Osteonics Corp. Omnifit M/S PSL Porous Coated Acetabular Shell 54MM;
Stryker Orthopaedics,
Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from Terminated |
MEH | None listed |
| Feb 7, 2011 | Stryker Howmedica Osteonics Corp. Omnifit M/S PSL Shell 58 MM;
Stryker Orthopaedics,
Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from degenerative arthritis, Terminated |
MEH | None listed |
| Feb 7, 2011 | Stryker Howmedica Osteonics Corp. Omnifit M/S Dual Geom Shell 58 MM;
Stryker Orthopaedics,
Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from degenerative art Terminated |
MEH | None listed |
| Feb 7, 2011 | Stryker Howmedica Osteonics Corp. Omnifit PSL M/S 3-Hole Cup, 46MM;
Stryker Orthopaedics,
Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from degenerative arthr Terminated |
MEH | None listed |
| Feb 7, 2011 | Stryker Howmedica Osteonics Corp. Omnifit PSL M/S 3-Hole Cup, 48MM;
Stryker Orthopaedics,
Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from degenerative arthr Terminated |
MEH | None listed |
| Feb 7, 2011 | Stryker Howmedica Osteonics Corp. Omnifit PSL M/S 3-Hole Cup, 50MM;
Stryker Orthopaedics,
Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from degenerative arthr Terminated |
MEH | None listed |
| Feb 7, 2011 | Stryker Howmedica Osteonics Corp. Omnifit PSL M/S 3-Hole Cup, 54MM;
Stryker Orthopaedics,
Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from degenerative arthr Terminated |
MEH | None listed |
| Feb 7, 2011 | Stryker Howmedica Osteonics Corp. Omnifit PSL M/S 3-Hole Cup, 58MM;
Stryker Orthopaedics,
Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from degenerative arthr Terminated |
MEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.