The following data is part of a premarket notification filed by Truemed Group Llc with the FDA for Arzzt Distal Radius And Ulna System.
| Device ID | K182650 |
| 510k Number | K182650 |
| Device Name: | Arzzt Distal Radius And Ulna System |
| Classification | Plate, Fixation, Bone |
| Applicant | Truemed Group LLC 2002 Timberloch Place Suite 200 The Woodlands, TX 77380 |
| Contact | Nina Galeana Rodriguez |
| Correspondent | Nina Galeana Rodriguez Truemed Group LLC 2002 Timberloch Place Suite 200 The Woodlands, TX 77380 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-24 |
| Decision Date | 2019-06-10 |