Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K112030
SYNTHES RADIAL HEAD PROSTHESIS SYSTEM · Synthes USA, LLC · decided 2012-06-19 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| (unnamed) | 03.402.719 | Synthes GmbH | KWI | 10886982080271 |
| (unnamed) | 04.402.030S | SYNTHES (U.S.A.) LP | KWI | 10886982128126 |
| (unnamed) | 03.402.727 | SYNTHES (U.S.A.) LP | KWI | 10886982080356 |
| (unnamed) | 03.402.020 | SYNTHES (U.S.A.) LP | KWI | 10886982079923 |
| (unnamed) | 09.402.424S | SYNTHES (U.S.A.) LP | KWI | 10886982132727 |
| (unnamed) | 03.402.626 | SYNTHES (U.S.A.) LP | KWI | 10886982080189 |
| (unnamed) | 03.402.722 | Synthes GmbH | KWI | 10886982080301 |
| (unnamed) | 03.402.010 | SYNTHES (U.S.A.) LP | KWI | 10886982079909 |
| (unnamed) | 03.402.009 | SYNTHES (U.S.A.) LP | KWI | 10886982079893 |
| (unnamed) | 03.402.728 | SYNTHES (U.S.A.) LP | KWI | 10886982080363 |
| (unnamed) | 09.402.022S | SYNTHES (U.S.A.) LP | KWI | 10886982132598 |
| (unnamed) | 09.402.020S | SYNTHES (U.S.A.) LP | KWI | 10886982132581 |
| (unnamed) | 09.402.428S | SYNTHES (U.S.A.) LP | KWI | 10886982132741 |
| (unnamed) | 03.402.624 | SYNTHES (U.S.A.) LP | KWI | 10886982080172 |
| (unnamed) | 03.402.732 | SYNTHES (U.S.A.) LP | KWI | 10886982080400 |
| (unnamed) | 04.402.010S | SYNTHES (U.S.A.) LP | KWI | 10886982128072 |
| (unnamed) | 03.402.024 | SYNTHES (U.S.A.) LP | KWI | 10886982079947 |
| (unnamed) | 04.402.006S | SYNTHES (U.S.A.) LP | KWI | 10886982128034 |
| (unnamed) | 03.402.734 | SYNTHES (U.S.A.) LP | KWI | 10886982080424 |
| (unnamed) | 09.402.422S | SYNTHES (U.S.A.) LP | KWI | 10886982132710 |
| (unnamed) | 03.402.718 | Synthes GmbH | KWI | 10886982080264 |
| (unnamed) | 03.402.007 | SYNTHES (U.S.A.) LP | KWI | 10886982079879 |
| (unnamed) | 03.402.622 | SYNTHES (U.S.A.) LP | KWI | 10886982080165 |
| (unnamed) | 03.402.022 | SYNTHES (U.S.A.) LP | KWI | 10886982079930 |
| (unnamed) | 09.402.028S | SYNTHES (U.S.A.) LP | KWI | 10886982132628 |