Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K211592
Avanti Orthopaedics Ulnar Shortening System · Avanti Orthopaedics, Inc. · decided 2021-07-16 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Lag Screw, 2.7mm x 17mm Long | LG2717 | AVANTI ORTHOPAEDICS LLC | HRS HWC | 00810054091387 |
| Lag Screw, 3.2mm x 26mm Long | LG3226 | AVANTI ORTHOPAEDICS LLC | HRS HWC | 00810054091578 |
| Jacking Screw (CS00 Sub-Component) | CSJSC | AVANTI ORTHOPAEDICS LLC | HRS HWC | 00810054091332 |
| Lag Screw, 3.2mm x 20mm Long | LG3220 | AVANTI ORTHOPAEDICS LLC | HRS HWC | 00810054091523 |
| Lag Screw, 3.2mm x 21mm Long | LG3221 | AVANTI ORTHOPAEDICS LLC | HRS HWC | 00810054091530 |
| Cutting Guide Screw | CGSCW | AVANTI ORTHOPAEDICS LLC | HRS HWC | 00810054091677 |
| Lag Screw, 2.7mm x 15mm Long | LG2715 | AVANTI ORTHOPAEDICS LLC | HRS HWC | 00810054091363 |
| Sled (CS00 Sub-Component) | CSSLD | AVANTI ORTHOPAEDICS LLC | HRS HWC | 00810054091714 |
| Lag Screw, 2.7mm x 12mm Long | LG2712 | AVANTI ORTHOPAEDICS LLC | HRS HWC | 00810054091349 |
| Lag Screw, 2.7mm x 14mm Long | LG2714 | AVANTI ORTHOPAEDICS LLC | HRS HWC | 00810054091356 |
| Lag Screw, 3.2mm x 16mm Long | LG3216 | AVANTI ORTHOPAEDICS LLC | HRS HWC | 00810054091486 |
| Lag Screw, 2.7mm x 24mm Long | LG2724 | AVANTI ORTHOPAEDICS LLC | HRS HWC | 00810054091448 |
| Cutting Guide, 2mm | CG02 | AVANTI ORTHOPAEDICS LLC | HRS HWC | 00810054091622 |
| Lag Screw, 3.2mm x 12mm Long | LG3212 | AVANTI ORTHOPAEDICS LLC | HRS HWC | 00810054091455 |
| Lag Screw, 2.7mm x 20mm Long | LG2720 | AVANTI ORTHOPAEDICS LLC | HRC HRS | 00810054091400 |
| Lid, Screw Side (USCD Sub-Component) | USLS | AVANTI ORTHOPAEDICS LLC | HRS HWC | 00810054091752 |
| Lag Screw, 2.7mm x 26mm Long | LG2726 | AVANTI ORTHOPAEDICS LLC | HRS HWC | 00810054091301 |
| Ulnar Shortening Caddy | USCD | AVANTI ORTHOPAEDICS LLC | HRS HWC | 00810054091745 |
| Lag Screw, 2.7mm x 21mm Long | LG2721 | AVANTI ORTHOPAEDICS LLC | HRS HWC | 00810054091417 |
| Lag Screw, 3.2mm x 23mm Long | LG3223 | AVANTI ORTHOPAEDICS LLC | HRS HWC | 00810054091554 |
| Lag Screw, 3.2mm x 14mm Long | LG3214 | AVANTI ORTHOPAEDICS LLC | HRS HWC | 00810054091462 |
| Ulnar Shortening Compression Plate, 7 Hole | USP07 | AVANTI ORTHOPAEDICS LLC | HRS HWC | 00810054091288 |
| Cutting Guide, 6mm | CG06 | AVANTI ORTHOPAEDICS LLC | HRS HWC | 00810054091660 |
| Cutting Guide, 3mm | CG03 | AVANTI ORTHOPAEDICS LLC | HRS HWC | 00810054091639 |
| Lid, Tool Side (USCD Sub-Component) | USLT | AVANTI ORTHOPAEDICS LLC | HRS HWC | 00810054091769 |