The following data is part of a premarket notification filed by Crossroads Extemity Systems, Llc with the FDA for Crossroads Screw System.
| Device ID | K191342 |
| 510k Number | K191342 |
| Device Name: | CrossRoads Screw System |
| Classification | Screw, 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 Ave Memphis, TN 38119 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-20 |
| Decision Date | 2019-08-19 |