510(k) K162775 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Legion Cone System
| Applicant | Smith & Nephew, Inc., Cordova TN, US |
| Decision | Substantially Equivalent, Jan 13, 2017 |
| Received | Oct 3, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162775
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 12, 2017 | Smith & Nephew, Inc. LEGION(R) FEM CONE IMPACTOR HEADS:
a) REF 71441976, ID 18MM
b) REF 71441977, ID 20MM
c) REF 71441978, ID 22MM Terminated |
JWH | None listed |
| Jun 12, 2017 | Smith & Nephew, Inc. LEGION(R) TIB CONE IMPACTOR HEADS:
a) REF 71441972, ID 24MM
b) REF 71441971, ID 22MM
c) REF 71441973, ID 26MM
d) REF 71441974, ID 28MM
e) REF 71441975, ID 30MM Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.