The following data is part of a premarket notification filed by Crossroads Extremity Systems, Llc with the FDA for Mis Bunion System.
| Device ID | K181872 |
| 510k Number | K181872 |
| Device Name: | MIS Bunion System |
| Classification | Plate, Fixation, Bone |
| Applicant | CrossRoads Extremity Systems, LLC 6055 Primacy Parkway, Suite 140 Memphis, TN 38119 |
| Contact | Chad Hollis |
| Correspondent | Theresa Leister MRC-X, LLC 6075 Poplar Ave Memphis, TN 38119 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-12 |
| Decision Date | 2019-02-19 |
| Summary: | summary |