Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K191118
Avanti Distal Radius and Forearm System · Avanti Orthopaedics, Inc. · decided 2019-12-13 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Non-Locking Screw, 2.7mm x 13mm Long | NS2713 | AVANTI ORTHOPAEDICS LLC | HRS HWC | 00810054090595 |
| Far Cortical Locking Screw, 2.7mm x 16mm Long | FS2716 | AVANTI ORTHOPAEDICS LLC | HRS HWC | 00810054090472 |
| Locking Screw, 2.7mm x 16mm Long | LS2716 | AVANTI ORTHOPAEDICS LLC | HRS HWC | 00810054090359 |
| Non-Locking Screw, 2.7mm x 26mm Long | NS2726 | AVANTI ORTHOPAEDICS LLC | HRS HWC | 00810054090670 |
| Drill, 2.7mm | DB27 | AVANTI ORTHOPAEDICS LLC | HRS HWC | 00810054090946 |
| Cannulated Screw, 2.7mm x 32mm Long | CS2732 | AVANTI ORTHOPAEDICS LLC | HRS HWC | 00810054090878 |
| Far Cortical Locking Screw, 2.7mm x 30mm Long | FS2730 | AVANTI ORTHOPAEDICS LLC | HRS HWC | 00810054090540 |
| Cannulated Screw, 2.7mm x 28mm Long | CS2728 | AVANTI ORTHOPAEDICS LLC | HRS HWC | 00810054090854 |
| Non-Locking Screw, 2.7mm x 28mm Long | NS2728 | AVANTI ORTHOPAEDICS LLC | HRS HWC | 00810054090687 |
| Locking Peg, 2.7mm x 12mm Long | PG2712 | AVANTI ORTHOPAEDICS LLC | HRS HWC | 00810054090717 |
| Locking Peg, 2.7mm x 8mm Long | PG2708 | AVANTI ORTHOPAEDICS LLC | HRS HWC | 00810054090694 |
| Cannulated Screw, 2.7mm x 36mm Long | CS2736 | AVANTI ORTHOPAEDICS LLC | HRS HWC | 00810054090892 |
| Spanning Plate, Standard | SPNS8 | AVANTI ORTHOPAEDICS LLC | HRS HWC | 00810054091240 |
| Volar Fixed Angle Plate, 3 Hole, Right | VFR03 | AVANTI ORTHOPAEDICS LLC | HRS HWC | 00810054090021 |
| Volar PEEK Plate, Wide, Left, 5 Hole | VWPL5 | AVANTI ORTHOPAEDICS LLC | HRS HWC | 00810054091783 |
| Far Cortical Locking Screw, 2.7mm x 26mm Long | FS2726 | AVANTI ORTHOPAEDICS LLC | HRS HWC | 00810054090526 |
| Wrist Fusion Plate, Standard Bend | WFSTD | AVANTI ORTHOPAEDICS LLC | HRS HWC | 00810054090298 |
| Volar PEEK Plate, 11 Hole, Left | VPL11 | AVANTI ORTHOPAEDICS LLC | HRS HWC | 00810054090151 |
| Avanti Cannulated Countersink, 2.7mm | SK27 | AVANTI ORTHOPAEDICS LLC | HRS HWC | 00810054091813 |
| Volar PEEK Plate, 3 Hole, Left | VPL03 | AVANTI ORTHOPAEDICS LLC | HRS HWC | 00810054090076 |
| Screw-In Guide, 2.0mm | SG20 | AVANTI ORTHOPAEDICS LLC | HRS HWC | 00810054091042 |
| Ulnar Plate, 5 Hole | ULP05 | AVANTI ORTHOPAEDICS LLC | HRS HWC | 00810054090175 |
| Volar PEEK Plate, 5 Hole, Right | VPR05 | AVANTI ORTHOPAEDICS LLC | HRS HWC | 00810054090106 |
| Volar Fixed Plate, Wide, 5 Hole, Left | VWL05 | AVANTI ORTHOPAEDICS LLC | HRS HWC | 00810054090052 |
| Cannulated Square Driver, 1.7mm | CD17 | AVANTI ORTHOPAEDICS LLC | HRS HWC | 00810054090977 |