510(k) K113848 ยท MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
R3 XLPE LINERS
| Applicant | Smith & Nephew, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Apr 27, 2012 |
| Received | Dec 29, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113848
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 8, 2013 | Smith & Nephew Inc R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 62 MM OD, QTY: (1), STERILE H2O2, REF 71335762.
Orthopaedic. Terminated |
MBL | None listed |
| Aug 8, 2013 | Smith & Nephew Inc R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 60 MM OD, QTY: (1), STERILE H2O2, REF 71335760.
Orthopaedic. Terminated |
MBL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.