The following data is part of a premarket notification filed by Skeletal Dynamics, Llc with the FDA for Align Radial Head System.
| Device ID | K172688 |
| 510k Number | K172688 |
| Device Name: | Align Radial Head System |
| Classification | Prosthesis, Elbow, Hemi-, Radial, Polymer |
| Applicant | Skeletal Dynamics, LLC 8905 SW 87 Avenue, Suite 201 Miami, FL 33176 |
| Contact | Ana M. Escagedo |
| Correspondent | Ana M. Escagedo Skeletal Dynamics, LLC 8905 SW 87 Avenue, Suite 201 Miami, FL 33176 |
| Product Code | KWI |
| CFR Regulation Number | 888.3170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-06 |
| Decision Date | 2017-12-22 |
| Summary: | summary |