510(k) K032295 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
GENESIS II POSTERIOR STABILIZED HIGH FLEXION ARTICULAR INSERT
| Applicant | Smith & Nephew, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Aug 21, 2003 |
| Received | Jul 25, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K032295
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 4, 2013 | Smith & Nephew Inc GENESIS(R) II, POSTERIOR STABILIZED ARTICULAR INSERT, SIZE 1-2, 13 MM QTY: (1), REF 71420806, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA
Orthopedic Terminated |
JWH | None listed |
| Dec 4, 2013 | Smith & Nephew Inc GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 13 MM QTY: (1), REF 71420820, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA
Orthopedic Terminated |
JWH | None listed |
| Dec 4, 2013 | Smith & Nephew Inc GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 9 MM QTY: (1), REF 71421508, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA
Orthopedic Terminated |
JWH | None listed |
| Dec 4, 2013 | Smith & Nephew Inc GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 9 MM QTY: (1), REF 71421515, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA
Orthopedic Terminated |
JWH | None listed |
| Dec 4, 2013 | Smith & Nephew Inc GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 11 MM QTY: (1), REF 71421516, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA
Orthopedic Terminated |
JWH | None listed |
| Dec 4, 2013 | Smith & Nephew Inc GENESIS(R) II, MOBILE BEARING ARTICULAR INSERT RIGHT, SIZE 5, 9 MM QTY: (1), REF 71621509, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA
Orthopedic Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.