510(k) K972770 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
ADVANCE ULTRA-CONGRUENT TIBIAL INSERT
| Applicant | Wrightmedicaltechnologyinc, Arlington TN, US |
| Decision | Substantially Equivalent, Oct 21, 1997 |
| Received | Jul 24, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972770
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 21, 2010 | Wright Medical Technology Inc ADVANCE DURAMER TIBIAL INSERT, REF: KIMP-312L, SIZE 3 LEFT MEDIAL PIVOT, THICKNESS 12MM, 1 EACH, STERILE EO, Wright Medical Technology, 4677 Airline Road, Arlington, TN 38002.
Indicated for use in k Terminated |
JWH | None listed |
| May 21, 2010 | Wright Medical Technology Inc ADVANCE DURAMER TIBIAL INSERT, REF: KIMP-312R SIZE 3 RIGHT MEDIAL PIVOT, THICKNESS 12MM, 1 EACH, STERILE EO, Wright Medical Technology, 4677 Airline Road, Arlington, TN 38002.
Indicated for use in Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.