510(k) K163497 · KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
EXPRT Revision Hip System - EXPRT Hip Distal Stem, EXPRT Hip Standard Offset Proximal Body Implant, EXPRT Hip Lateral Offset Proximal Body Implant, EXPRT Hip Capture Bolt
| Applicant | Encore Medical L.P., Austin TX, US |
| Decision | Substantially Equivalent, Mar 2, 2017 |
| Received | Dec 13, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163497
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 21, 2018 | Encore Medical, Lp Exprt Precision System: Revision Hip, Proximal Body with Bolt, Lateral Offset, Sterile R, djo surgical,
REF: 495-00-065, 495-00-075, 495-00-085,
495-01-065, 495-01-075, 495-01-085 Terminated |
KWZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.