510(k) K110836 ยท KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY
| Applicant | Zimmer GmbH, Warsaw IN, US |
| Decision | Substantially Equivalent, Oct 7, 2011 |
| Received | Mar 25, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110836
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 10, 2019 | Zimmer Biomet, Inc. CLS Brevius Stem Kinectiv, hip prosthesis, various sizes. Item Nos. 0100296050
0100296060
0100296070
0100296080
0100296090
0100296100
0100296112
0100296125
0100296137
0100296150
0100296162
0100296175
Terminated |
LZO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.