The following data is part of a premarket notification filed by Akros Medical with the FDA for Akros Scruture Anchor Lisfranc Repair Kit.
| Device ID | K200361 |
| 510k Number | K200361 |
| Device Name: | Akros Scruture Anchor LisFranc Repair Kit |
| Classification | Washer, Bolt Nut |
| Applicant | Akros Medical 3503 Pleasant Green Rd Durham, NC 27705 |
| Contact | Charles Horrell |
| Correspondent | Charles Horrell Akros Medical 3503 Pleasant Green Rd Durham, NC 27705 |
| Product Code | HTN |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-14 |
| Decision Date | 2020-04-06 |