The following data is part of a premarket notification filed by Crossroads Extemity Systems, Llc with the FDA for Trimax Implant System.
| Device ID | K190722 |
| 510k Number | K190722 |
| Device Name: | TriMAX Implant System |
| Classification | Staple, Fixation, Bone |
| Applicant | CrossRoads Extemity Systems, LLC 6055 Primacy Pkwy Suite 140 Memphis, TN 38119 |
| Contact | Chad Hollis |
| Correspondent | Theresa Leister MRC X, LLC 6075 Poplar Avenue Memphis, TN 38119 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-20 |
| Decision Date | 2019-08-16 |