The following data is part of a premarket notification filed by Miami Device Solutions, Llc with the FDA for Distal Radius Plating System.
| Device ID | K161292 |
| 510k Number | K161292 |
| Device Name: | Distal Radius Plating System |
| Classification | Plate, Fixation, Bone |
| Applicant | MIAMI DEVICE SOLUTIONS, LLC 7620 NW 25TH STREET UNIT 3 Miami, FL 33122 |
| Contact | Markku Biedermann |
| Correspondent | Michelle Montesino MIAMI DEVICE SOLUTIONS, LLC 7620 NW 25TH STREET UNIT 3 Miami, FL 33122 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-09 |
| Decision Date | 2016-08-15 |
| Summary: | summary |