The following data is part of a premarket notification filed by Conventus Orthopaedics, Inc. with the FDA for Conventus Orthopaedics Ulna Fixation System.
| Device ID | K161048 |
| 510k Number | K161048 |
| Device Name: | Conventus Orthopaedics Ulna Fixation System |
| Classification | Plate, Fixation, Bone |
| Applicant | CONVENTUS ORTHOPAEDICS, INC. 10200 73RD AVENUE NORTH, SUITE 122 Maple Grove, MN 55369 |
| Contact | Kent Lind |
| Correspondent | Kent Lind CONVENTUS ORTHOPAEDICS, INC. 10200 73RD AVENUE NORTH, SUITE 122 Maple Grove, MN 55369 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-14 |
| Decision Date | 2016-07-26 |
| Summary: | summary |