Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K193280
MedCAD® AccuPlate® Patient-Specific Plate · Medcad · decided 2021-02-12 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| AccuPlate® Patient-Specific Plate | ZB-PLT005 | Medcad | JEY | 00810007630915 |
| AccuPlate | ZB-K035 | Medcad | JEY | 00810007631080 |
| AccuPlate | MC-PLT004 | Medcad | JEY | 00810007630489 |
| AccuPlate | MC-PLT324 | Medcad | JEY | 00810007632865 |
| AccuPlate | ZB-PLT013 | Medcad | JEY | 00810007632933 |
| AccuPlate | MC-K035 | Medcad | JEY | 00810007630410 |
| AccuPlate | MC-PLT310 | Medcad | JEY | 00810007632766 |
| AccuPlate | MC-PLT007 | Medcad | JEY | 00810007630519 |
| AccuPlate | MC-PLT011 | Medcad | JEY | 00810007630564 |
| AccuPlate | MC-PLT314 | Medcad | JEY | 00810007632803 |
| AccuPlate | MC-PLT001 | Medcad | JEY | 00810007630458 |
| AccuPlate | ZB-PLT022 | Medcad | JEY | 00810007631134 |
| AccuPlate® Patient-Specific Plate | ZB-PLT004 | Medcad | JEY | 00810007630908 |
| AccuPlate® Patient-Specific Plate | ZB-PLT009 | Medcad | JEY | 00810007630953 |
| AccuPlate | MC-PLT010 | Medcad | JEY | 00810007630557 |
| AccuPlate® Patient-Specific Plate | ZB-PLT002 | Medcad | JEY | 00810007630885 |
| AccuPlate | ZB-PLT313 | Medcad | JEY | 00810007633107 |
| AccuPlate | MC-PLT311 | Medcad | JEY | 00810007632773 |
| AccuPlate | MC-PLT022 | Medcad | JEY | 00810007631493 |
| AccuStride System | MC-STP001 | Medcad | JEY | 00810007633329 |
| AccuPlate | MC-PLT308 | Medcad | JEY | 00810007632742 |
| AccuPlate | MC-PLT315 | Medcad | JEY | 00810007632810 |
| AccuPlate® Patient-Specific Plate | ZB-PLT012 | Medcad | JEY | 00810007630984 |
| AccuPlate | ZB-PLT303 | Medcad | JEY | 00810007633008 |
| AccuPlate | MC-PLT323 | Medcad | JEY | 00810007632858 |