The following data is part of a premarket notification filed by Acumed, Llc with the FDA for Acumed Ankle Plating System.
| Device ID | K143385 |
| 510k Number | K143385 |
| Device Name: | Acumed Ankle Plating System |
| Classification | Plate, Fixation, Bone |
| Applicant | Acumed, Llc 5885 NW Cornelius Pass Road Hillsboro, OR 97124 |
| Contact | Nathan Wolf |
| Correspondent | Nathan Wolf Acumed, Llc 5885 NW Cornelius Pass Road Hillsboro, OR 97124 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-26 |
| Decision Date | 2015-04-06 |
| Summary: | summary |