The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Evos Straight Proximal Humerus 7-15 Hole Plates (137-225mm).
| Device ID | K201527 |
| 510k Number | K201527 |
| Device Name: | EVOS Straight Proximal Humerus 7-15 Hole Plates (137-225mm) |
| Classification | Plate, Fixation, Bone |
| Applicant | Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Contact | Kayla Franklin |
| Correspondent | Kayla Franklin Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-08 |
| Decision Date | 2020-07-22 |