The following data is part of a premarket notification filed by Acumed Llc with the FDA for Acumed Ankle Syndesmosis Repair System.
| Device ID | K212990 |
| 510k Number | K212990 |
| Device Name: | Acumed Ankle Syndesmosis Repair System |
| Classification | Washer, Bolt Nut |
| Applicant | Acumed LLC 5885 NE Cornelius Pass Road Hillsboro, OR 97124 |
| Contact | Janki Bhatt |
| Correspondent | Janki Bhatt Acumed LLC 5885 NE Cornelius Pass Road Hillsboro, OR 97124 |
| Product Code | HTN |
| Subsequent Product Code | HTW |
| Subsequent Product Code | LXH |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-20 |
| Decision Date | 2022-01-07 |