The following data is part of a premarket notification filed by Crossroads Extremity Systems, Llc with the FDA for Foothold System.
| Device ID | K220797 |
| 510k Number | K220797 |
| Device Name: | FootHold System |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | CrossRoads Extremity Systems, LLC 6423 Shelby View Dr., Suite 101 Memphis, TN 38134 |
| Contact | Kim Strohkirch |
| Correspondent | Kim Strohkirch CrossRoads Extremity Systems, LLC 6423 Shelby View Dr., Suite 101 Memphis, TN 38134 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-18 |
| Decision Date | 2022-04-15 |