The following data is part of a premarket notification filed by Jm Longyear Manufacturing, Llc D/b/a Able Medical Devices with the FDA for Valkyrie Thoracic Fixation System.
| Device ID | K211695 |
| 510k Number | K211695 |
| Device Name: | Valkyrie Thoracic Fixation System |
| Classification | Plate, Fixation, Bone |
| Applicant | JM Longyear Manufacturing, LLC D/b/a Able Medical Devices 512 4th Street Gwinn, MI 49841 |
| Contact | Wade Depas |
| Correspondent | Wade Depas JM Longyear Manufacturing, LLC D/b/a Able Medical Devices 512 4th Street Gwinn, MI 49841 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-02 |
| Decision Date | 2021-06-23 |