The following data is part of a premarket notification filed by Miami Device Solutions with the FDA for Proximal Humerus Plating System.
| Device ID | K141493 |
| 510k Number | K141493 |
| Device Name: | PROXIMAL HUMERUS PLATING SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | Miami Device Solutions 631 SE 11TH STREET Pompano Beach, FL 33060 |
| Contact | Peter J Mincieli |
| Correspondent | Peter J Mincieli Miami Device Solutions 631 SE 11TH STREET Pompano Beach, FL 33060 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-05 |
| Decision Date | 2015-03-20 |
| Summary: | summary |