The following data is part of a premarket notification filed by Crossroads Extremity Systems, Llc with the FDA for Stropp (single Tunnel Repair Of Plantar Plate).
| Device ID | K160118 |
| 510k Number | K160118 |
| Device Name: | STROPP (Single Tunnel Repair Of Plantar Plate) |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | CROSSROADS EXTREMITY SYSTEMS, LLC 6055 PRIMACY PKWY SUITE 140 Memphis, TN 38119 |
| Contact | Vernon Hartdegen |
| Correspondent | Vernon Hartdegen CROSSROADS EXTREMITY SYSTEMS, LLC 6055 PRIMACY PKWY SUITE 140 Memphis, TN 38119 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-19 |
| Decision Date | 2016-05-03 |
| Summary: | summary |