The following data is part of a premarket notification filed by Skeletal Dynamics, Inc. with the FDA for Hand Trauma Screw System.
| Device ID | K220723 |
| 510k Number | K220723 |
| Device Name: | Hand Trauma Screw System |
| Classification | Screw, 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 | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-14 |
| Decision Date | 2022-05-12 |