Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K200062
Foot and Ankle System · Leith Medical, LLC · decided 2021-02-22 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Leith Medical MTP Plating System | 0810-2056 | Leith Medical LLC | HRS | B953081020560 |
| Leith Medical MTP Plating System | 0810-1062 | Leith Medical LLC | HRS | B953081010620 |
| Leith Medical Plating System | 0300-0009 | Leith Medical LLC | HRS | B953030000090 |
| Leith Medical 2.7mm Cortical Screw | 1027-0024 | Leith Medical LLC | HWC | B953102700240 |
| Leith Medical 3.5mm Cortical Screw | 1035-0050 | Leith Medical LLC | HWC | B953103500500 |
| Leith Medical 2.7mm Cortical Screw | 1027-0034 | Leith Medical LLC | HWC | B953102700340 |
| Leith Medical Lapidus Plating System | 0100-0503-L | Leith Medical LLC | HRS | B95301000503L0 |
| Leith Medical Lapidus Plating System | 0100-1003-R | Leith Medical LLC | HRS | B95301001003R0 |
| Leith Medical Lapidus Plating System | 0100-0004-R | Leith Medical LLC | HRS | B95301000004R0 |
| Leith Medical 2.7mm Cortical Screw | 1027-0042 | Leith Medical LLC | HWC | B953102700420 |
| Leith Medical Plating System Instruments | 0700-TRIAL-L | Leith Medical LLC | HRS HWC | B9530700TRIALL0 |
| Leith Medical Lapidus Plating System | 0100-0004-L | Leith Medical LLC | HRS | B95301000004L0 |
| Leith Medical 2.7mm Cortical Screw | 1027-0016 | Leith Medical LLC | HWC | B953102700160 |
| Leith Medical Lateral Fibular Plating System | 0500-1132 | Leith Medical LLC | HRS | B953050011320 |
| Leith Medical Lapidus Plating System | 0100-0500-R | Leith Medical LLC | HRS | B95301000500R0 |
| Leith Medical 3.5mm Cortical Screw | 1035-0026 | Leith Medical LLC | HWC | B953103500260 |
| Leith Medical Plating System Instruments | 0800-TRIAL-R | Leith Medical LLC | HRS HWC | B9530800TRIALR0 |
| Leith Medical Plating System Instruments | 0300-TRIAL | Leith Medical LLC | HRS HWC | B9530300TRIAL0 |
| Leith Medical MTP Plating System | 0805-1056 | Leith Medical LLC | HRS | B953080510560 |
| Leith Medical Plating System Instruments | 0600-TRIAL | Leith Medical LLC | HRS HWC | B9530600TRIAL0 |
| Leith Medical Anterolateral Tibial Plating System | 0400-2113 | Leith Medical LLC | HRS | B953040021130 |
| Leith Medical Plating System | 0300-0005 | Leith Medical LLC | HRS | B953030000050 |
| Leith Medical Lapidus Plating System | 0100-1500-L | Leith Medical LLC | HRS | B95301001500L0 |
| Leith Medical TMT Plating System | 0200-0360 | Leith Medical LLC | HRS | B953020003600 |
| Leith Medical Medial Malleolar Plating System | 0700-2087 | Leith Medical LLC | HRS | B953070020870 |