510(k) K140898 ยท KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
PATIENT SPECIFIC DISTAL FEMORAL
| Applicant | Stanmore Implants Worldwide , Ltd., Plymouth MA, US |
| Decision | Substantially Equivalent, Jan 20, 2015 |
| Received | Apr 8, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K140898
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 23, 2022 | Howmedica Osteonics Corp. Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component. Open, Classified |
KRQ | None listed |
| Jul 4, 2017 | Stanmore Implants Worldwide Ltd. JTS External Drive Unit
JTS Distal Femoral Extendible Implant Femur is intended for the replacement of diseased or deficient bone in the distal femur. Terminated |
KRO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.