510(k) K060670 ยท HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
ACCIN UNI-KNEE SYSTEM
| Applicant | Accin Corporation, Clifton NJ, US |
| Decision | Substantially Equivalent, Jun 2, 2006 |
| Received | Mar 14, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060670
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 3, 2017 | Arthrex, Inc. iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL, REF AR 501-UFLC, QTY 1, Rx ONLY, STERILE R, Arthrex, Inc., Naples, FL
Indicated for use in uni-compartmental knee arthroplasty as Terminated |
HSX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.