510(k) K960094 ยท MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
REFLECTION DUAL DIMENSION SHELL
| Applicant | Smith & Nephew Richards, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Mar 27, 1996 |
| Received | Jan 11, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K960094
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 21, 2014 | Smith & Nephew Inc Reflection Interfit Shell, 52 MM OD, 3 HOLE, REF 71336052, QTY 1, STERILE R, Smith & Nephew, Inc.
Indications for use include cemented or uncemented total hip arthroplasty for rheumatoid arthritis; Terminated |
MBL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.