510(k) K042344 ยท LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
EXCIA TOTAL HIP SYSTEM
| Applicant | Aesculap, Inc., Center Valley PA, US |
| Decision | Substantially Equivalent, Mar 16, 2005 |
| Received | Aug 30, 2004 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K042344
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 11, 2007 | Aesculap Implant Systems Excia Cemented Hip Stems, Size 9mm, Part Number: NJ309K, Aesculap Implant Systems, Inc., Center Valley, PA 18034 Terminated |
LWJ | None listed |
| Dec 11, 2007 | Aesculap Implant Systems Excia Cemented Hip Stems, Size 10mm, Part Number: NJ310K, Aesculap Implant Systems, Inc., Center Valley, PA 18034 Terminated |
LWJ | None listed |
| Dec 11, 2007 | Aesculap Implant Systems Excia Cemented Hip Stems, Size 11mm, Part Number : NJ311K, Aesculap Implant Systems, Inc., Center Valley, PA 18034 Terminated |
LWJ | None listed |
| Dec 11, 2007 | Aesculap Implant Systems Excia Cemented Hip Stems, Size 12mm, Part Number: NJ312K, Aesculap Implant Systems, Inc., Center Valley, PA 18034 Terminated |
LWJ | None listed |
| Dec 11, 2007 | Aesculap Implant Systems Excia Cemented Hip Stems, Size 13mm, Part Number : NJ313K, Aesculap Implant Systems, Inc., Center Valley, PA 18034 Terminated |
LWJ | None listed |
| Dec 11, 2007 | Aesculap Implant Systems Excia Cemented Hip Stems, Size 14mm, Part Number : NJ314K, Aesculap Implant Systems, Inc., Center Valley, PA 18034 Terminated |
LWJ | None listed |
| Dec 11, 2007 | Aesculap Implant Systems Excia Cemented Hip Stems, Size 15mm, Part Number: NJ315K Aesculap Implant Systems, Inc., Center Valley, PA 18034 Terminated |
LWJ | None listed |
| Dec 11, 2007 | Aesculap Implant Systems Excia Cemented Hip Stems, Size 16mm, Part Number NJ316K, Aesculap Implant Systems, Inc., Center Valley, PA 18034 Terminated |
LWJ | None listed |
| Dec 11, 2007 | Aesculap Implant Systems Excia Cemented Hip Stems, Size 17mm, Part Number : NJ317K, Aesculap Implant Systems, Inc., Center Valley, PA 18034 Terminated |
LWJ | None listed |
| Dec 11, 2007 | Aesculap Implant Systems Excia Cemented Hip Stems ,Size 18mm, Part Number NJ318K, Aesculap Implant Systems, Inc., Center Valley, PA 18034 Terminated |
LWJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.