510(k) K110404 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
EAUM TOTAL KNEE SYSTEM
| Applicant | Corentec Co., Ltd., San Diego CA, US |
| Decision | Substantially Equivalent, Feb 16, 2012 |
| Received | Feb 14, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110404
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 31, 2024 | CORENTEC CO., LTD LOSPA Tibial Insert
Model/Catalog Number: See below
Software Version: N/A
Product Description: Tibial Insert Open, Classified |
JWH | None listed |
| May 31, 2024 | CORENTEC CO., LTD LOSPA Patella Component
Model/Catalog Number: 01.10.9XX
Software Version: N/A
Product Description: Patella Open, Classified |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.