The following data is part of a premarket notification filed by Avanti Orthopaedics, Inc. with the FDA for Avanti Orthopaedics Ulnar Shortening System.
| Device ID | K211592 |
| 510k Number | K211592 |
| Device Name: | Avanti Orthopaedics Ulnar Shortening System |
| Classification | Plate, Fixation, Bone |
| Applicant | Avanti Orthopaedics, Inc. 4606 Simon Road Wilmington, DE 19803 |
| Contact | J. Doug Patterson |
| Correspondent | Linda Braddon Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock, GA 30188 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-24 |
| Decision Date | 2021-07-16 |