Recognized a 510(k)/PMA number — showing its clearance record and devices.
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Pivot Bipolar | 133-2847 | Ortho Development Corporation | KWY | 00822409015313 |
| Pivot Bipolar | 133-2260 | Ortho Development Corporation | KWY | 00822409015290 |
| Pivot Bipolar | 133-2244 | Ortho Development Corporation | KWY | 00822409015139 |
| Pivot Bipolar | 133-2846 | Ortho Development Corporation | KWY | 00822409015306 |
| Pivot Bipolar | 133-2241 | Ortho Development Corporation | KWY | 00822409015108 |
| Pivot Bipolar | 133-2252 | Ortho Development Corporation | KWY | 00822409015214 |
| Pivot Bipolar | 133-2258 | Ortho Development Corporation | KWY | 00822409015276 |
| Pivot Bipolar | 133-2245 | Ortho Development Corporation | KWY | 00822409015146 |
| Pivot Bipolar | 133-2851 | Ortho Development Corporation | KWY | 00822409015351 |
| Pivot Bipolar | 133-2240 | Ortho Development Corporation | KWY | 00822409010226 |
| Pivot Bipolar | 133-2255 | Ortho Development Corporation | KWY | 00822409015245 |
| Pivot Bipolar | 133-2243 | Ortho Development Corporation | KWY | 00822409015122 |
| Pivot Bipolar | 133-2848 | Ortho Development Corporation | KWY | 00822409015320 |
| Pivot Bipolar | 133-2853 | Ortho Development Corporation | KWY | 00822409015375 |
| Pivot Bipolar | 133-2249 | Ortho Development Corporation | KWY | 00822409015184 |
| Pivot Bipolar | 133-2248 | Ortho Development Corporation | KWY | 00822409015177 |
| Pivot Bipolar | 133-2858 | Ortho Development Corporation | KWY | 00822409015429 |
| Pivot Bipolar | 133-2238 | Ortho Development Corporation | KWY | 00822409015085 |
| Pivot Bipolar | 133-2855 | Ortho Development Corporation | KWY | 00822409015399 |
| Pivot Bipolar | 133-2854 | Ortho Development Corporation | KWY | 00822409015382 |
| Pivot Bipolar | 133-2849 | Ortho Development Corporation | KWY | 00822409015337 |
| Pivot Bipolar | 133-2239 | Ortho Development Corporation | KWY | 00822409015092 |
| Pivot Bipolar | 133-2860 | Ortho Development Corporation | KWY | 00822409015443 |
| Pivot Bipolar | 133-2254 | Ortho Development Corporation | KWY | 00822409015238 |
| Pivot Bipolar | 133-2250 | Ortho Development Corporation | KWY | 00822409015191 |