510(k) K993335 ยท HTO Reamer
SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM
| Applicant | Synthes (Usa), Paoli PA, US |
| Decision | Substantially Equivalent, Jun 12, 2000 |
| Received | Oct 4, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993335
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 19, 2020 | Synthes (USA) Products LLC DePuy Synthes 10.0MM REAMER HEAD FOR RIA 2, STERILE-Orthopedic manual surgical instrument
Part Code: 03.404.016S Terminated |
HTO | None listed |
| Nov 19, 2020 | Synthes (USA) Products LLC DePuy Synthes 10.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument
Part Code: 03.404.017S Terminated |
HTO | None listed |
| Nov 19, 2020 | Synthes (USA) Products LLC DePuy Synthes 11.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument
Part Code: 03.404.018S Terminated |
HTO | None listed |
| Nov 19, 2020 | Synthes (USA) Products LLC DePuy Synthes 11.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument
Part Code: 03.404.019S Terminated |
HTO | None listed |
| Nov 19, 2020 | Synthes (USA) Products LLC DePuy Synthes 12.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument
Part Code: 03.404.020S Terminated |
HTO | None listed |
| Nov 19, 2020 | Synthes (USA) Products LLC DePuy Synthes 12.5MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument
Part Code: 03.404.021S Terminated |
HTO | None listed |
| Nov 19, 2020 | Synthes (USA) Products LLC DePuy Synthes 13.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument
Part Code: 03.404.022S Terminated |
HTO | None listed |
| Nov 19, 2020 | Synthes (USA) Products LLC DePuy Synthes 13.5MM REAMER HEAD FOR RIA 2
STERILE-Orthopedic manual surgical instrument
Part Code: 03.404.023S Terminated |
HTO | None listed |
| Nov 19, 2020 | Synthes (USA) Products LLC DePuy Synthes 14.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument
Part Code: 03.404.024S Terminated |
HTO | None listed |
| Nov 19, 2020 | Synthes (USA) Products LLC DePuy Synthes 14.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument
Part Code: 03.404.025S Terminated |
HTO | None listed |
| Nov 19, 2020 | Synthes (USA) Products LLC DePuy Synthes 15.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument
Part Code: 03.404.026S Terminated |
HTO | None listed |
| Nov 19, 2020 | Synthes (USA) Products LLC DePuy Synthes 15.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument
Part Code: 03.404.027S Terminated |
HTO | None listed |
| Nov 19, 2020 | Synthes (USA) Products LLC DePuy Synthes 16.0MM REAMER HEAD FOR RIA 2 STERILE--Orthopedic manual surgical instrument
Part Code: 03.404.028S Terminated |
HTO | None listed |
| Nov 19, 2020 | Synthes (USA) Products LLC DePuy Synthes 16.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument
Part Code: 03.404.029S Terminated |
HTO | None listed |
| Nov 19, 2020 | Synthes (USA) Products LLC DePuy Synthes 17.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument
Part Code: 03.404.030S Terminated |
HTO | None listed |
| Nov 19, 2020 | Synthes (USA) Products LLC DePuy Synthes 17.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument
Part Code: 03.404.031S Terminated |
HTO | None listed |
| Nov 19, 2020 | Synthes (USA) Products LLC DePuy Synthes 18.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument
Part Code: 03.404.032S Terminated |
HTO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.