510(k) K123598 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATION
| Applicant | Smith & Nephew, Inc., Cordova TN, US |
| Decision | Substantially Equivalent, Jun 28, 2013 |
| Received | Nov 21, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123598
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 7, 2019 | Smith & Nephew, Inc. SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613 Terminated |
LXH | None listed |
| Nov 16, 2016 | Smith & Nephew, Inc. REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116 Terminated |
JDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.