510(k) K053536 ยท KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS
| Applicant | Zimmer GmbH, Warsaw IN, US |
| Decision | Substantially Equivalent, Mar 16, 2006 |
| Received | Dec 19, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053536
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 6, 2012 | Zimmer, Inc. Kopf Adapter S
Sterile, Rx Terminated |
KWA | None listed |
| Sep 26, 2008 | Zimmer Inc. Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 44/38, code D, Zimmer, Winterthur, Switzerland; REF 01.00214.144. The product is component of the Metasul LDH Head System intended fo Terminated |
KWA | None listed |
| Sep 26, 2008 | Zimmer Inc. Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 46/40, code F, Zimmer, Winterthur, Switzerland; REF 01.00214.146. The product is component of the Metasul LDH Head System intended f Terminated |
KWA | None listed |
| Sep 26, 2008 | Zimmer Inc. Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 48/42, code H, Zimmer, Winterthur, Switzerland; REF 01.00214.148. The product is component of the Metasul LDH Head System intended f Terminated |
KWA | None listed |
| Sep 26, 2008 | Zimmer Inc. Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 50/44, code J, Zimmer, Winterthur, Switzerland; REF 01.00214.150. The product is component of the Metasul LDH Head System intended f Terminated |
KWA | None listed |
| Sep 26, 2008 | Zimmer Inc. Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 52/46, code L, Zimmer, Winterthur, Switzerland; REF 01.00214.152. The product is component of the Metasul LDH Head System intended fo Terminated |
KWA | None listed |
| Sep 26, 2008 | Zimmer Inc. Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 54/48, code N, Zimmer, Winterthur, Switzerland; REF 01.00214.154. The product is component of the Metasul LDH Head System intended f Terminated |
KWA | None listed |
| Sep 26, 2008 | Zimmer Inc. Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 56/50, code P, Zimmer, Winterthur, Switzerland; REF 01.00214.156. The product is component of the Metasul LDH Head System intended f Terminated |
KWA | None listed |
| Sep 26, 2008 | Zimmer Inc. Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 58/52, code R, Zimmer, Winterthur, Switzerland; REF 01.00214.158. The product is component of the Metasul LDH Head System intended fo Terminated |
KWA | None listed |
| Sep 26, 2008 | Zimmer Inc. Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 60/54, code T, Zimmer, Winterthur, Switzerland; REF 01.00214.160. The product is component of the Metasul LDH Head System intended Terminated |
KWA | None listed |
| Sep 26, 2008 | Zimmer Inc. Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 62/56, code V, Zimmer, Winterthur, Switzerland; REF 01.00214.162. The product is component of the Metasul LDH Head System intended f Terminated |
KWA | None listed |
| Sep 26, 2008 | Zimmer Inc. Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 64/58, code X, Zimmer, Winterthur, Switzerland; REF 01.00214.164. The product is component of the Metasul LDH Head System intended f Terminated |
KWA | None listed |
| Sep 26, 2008 | Zimmer Inc. Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 66/60, code Z, Zimmer, Winterthur, Switzerland; REF 01.00214.166. The product is component of the Metasul LDH Head System intended f Terminated |
KWA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.