510(k) K990666 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
HYDROXYAPATITE (HA) REFLECTION ACETABULAR SHELL, HYDROXYAPATITE (HA) REFLECTION INTERFIT SHELL
| Applicant | Smith & Nephew, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Aug 6, 1999 |
| Received | Mar 2, 1999 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K990666
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 28, 2016 | Smith & Nephew, Inc. SPHERICAL HEAD REFLECTION(R) 6.5 MM CANCELLOUS SCREW, REF 71332525, QTY: (1), STERILE R, smith&nephew
Total hip components are indicated for individuals undergoing primary or revision surgery where ot Terminated |
MEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.