510(k) K063279 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
NOVATION SPLINED RDD FEMORAL STEMS
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Nov 29, 2006 |
| Received | Oct 31, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K063279
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 26, 2016 | Exactech, Inc. Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 17.
Product Usage Femoral stems are indicated for use in skeletally mature individuals undergoing primary su Terminated |
LZO | None listed |
| May 26, 2016 | Exactech, Inc. Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 18.
Femoral stems are indicated for use in skeletally mature individuals undergoing primary surgery for hip Terminated |
LZO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.