The following data is part of a premarket notification filed by Crossroads Extremity Systems Llc with the FDA for Crosstie Intraosseous Fixation System.
| Device ID | K151270 |
| 510k Number | K151270 |
| Device Name: | CrossTIE Intraosseous Fixation System |
| Classification | Screw, Fixation, Bone |
| Applicant | CrossRoads Extremity Systems LLC 6055 Primacy Parkway, Suite 140 Memphis, TN 38119 |
| Contact | Vernon Hartdegen |
| Correspondent | Vernon Hartdegen CrossRoads Extremity Systems LLC 6055 Primacy Parkway, Suite 140 Memphis, TN 38119 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-13 |
| Decision Date | 2015-09-04 |
| Summary: | summary |