510(k) K181607 ยท JDQ Cerclage, Fixation
Thorecon Rigid Fixation System
| Applicant | A & E Medical Corporation, Farmingdale NJ, US |
| Decision | Substantially Equivalent, Oct 12, 2018 |
| Received | Jun 19, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181607
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 10, 2019 | Alto Development Corp A&E Medical Thorecon Plating System Kits Model No. 94-1200-08. For fracture fixation or reconstruction of the sternum. Terminated |
JDQ | None listed |
| Sep 10, 2019 | Alto Development Corp A&E Medical Thorecon Plating System Kits Model No. 94-1300-04-S. For fracture fixation or reconstruction of the sternum. Terminated |
JDQ | None listed |
| Sep 10, 2019 | Alto Development Corp A&E Medical Thorecon Plating System Kits Model No. 94-1400-04. For fracture fixation or reconstruction of the sternum. Terminated |
JDQ | None listed |
| Sep 10, 2019 | Alto Development Corp A&E Medical Thorecon Plating System Kits Model No. 94-1500-04-S. For fracture fixation or reconstruction of the sternum. Terminated |
JDQ | None listed |
| Sep 10, 2019 | Alto Development Corp A&E Medical Thorecon Plating System Kits Model No. 94-1700-10. For fracture fixation or reconstruction of the sternum. Terminated |
JDQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.