The following data is part of a premarket notification filed by Skeletal Dynamics, Inc. with the FDA for Distal Humerus Plating System.
| Device ID | K213895 |
| 510k Number | K213895 |
| Device Name: | Distal Humerus Plating System |
| Classification | Plate, Fixation, Bone |
| Applicant | Skeletal Dynamics, Inc. 7300 N. Kendall Drive, Suite 400 Miami, FL 33156 |
| Contact | Alexandra Rodriguez |
| Correspondent | Alexandra Rodriguez Skeletal Dynamics, Inc. 7300 N. Kendall Drive, Suite 400 Miami, FL 33156 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-14 |
| Decision Date | 2022-01-13 |