Clearance Summary
Able Medical Devices Valkyrie Thoracic Fixation System received FDA 510(k) clearance under submission number K202889, sponsored by Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2021-03-02.
- Submission: K202889
- Applicant / Sponsor: Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2021-03-02
Classification & Regulation
This clearance is catalogued under FDA product code HRS and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.