The following data is part of a premarket notification filed by Akros Medical with the FDA for Akros Fibulink Syndesmosis Repair Kit.
| Device ID | K162805 |
| 510k Number | K162805 |
| Device Name: | Akros Fibulink Syndesmosis 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 | 2016-10-05 |
| Decision Date | 2017-01-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00863176000300 | K162805 | 000 |