The following data is part of a premarket notification filed by Skeletal Dynamics, Inc. with the FDA for Small Bone Nailing System.
| Device ID | K211439 |
| 510k Number | K211439 |
| Device Name: | Small Bone Nailing System |
| Classification | Pin, Fixation, Smooth |
| Applicant | Skeletal Dynamics, Inc. 7300 N. Kendall Drive, Suite 400 Miami, FL 33156 |
| Contact | Ana M Escagedo |
| Correspondent | Ana M Escagedo Skeletal Dynamics, Inc. 7300 N. Kendall Drive, Suite 400 Miami, FL 33156 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-10 |
| Decision Date | 2021-09-30 |